Supac
30/06/10
Generic Name: acetaminophen, aspirin, and caffeine (ah SEET a MIN oh fen, ASP i rin, and KAF een)
Brand Names: Anacin Advanced Headache Formula, Excedrin, Excedrin Express Gels, Excedrin Extra Strength, Excedrin Extra Strength Geltab, Excedrin Geltab, Excedrin Menstrual Express Gels, Excedrin Migraine, Excedrin Migraine Geltab, Genace, Goodys Extra Strength, Goodys Headache Powders, Pain Reliever Plus
What is Supac (acetaminophen, aspirin, and caffeine)?
Acetaminophen is a pain reliever and a fever reducer.
Aspirin is in a group of drugs called salicylates (sa-LIS-il-ates). It works by reducing substances in the body that cause pain, fever, and inflammation.
Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.
The combination of acetaminophen, aspirin, and caffeine is used to treat pain caused by tension headaches, migraine headaches, muscle aches, menstrual cramps, arthritis, toothaches, the common cold, or nasal congestion.
Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.
Acetaminophen, aspirin, and caffeine may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about Supac (acetaminophen, aspirin, and caffeine)?
Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye’s syndrome in children. You should not use this medication if you are allergic to acetaminophen (Tylenol), aspirin, or caffeine, or if you have liver disease, stomach or intestinal bleeding, a history of asthma or severe allergic reaction to aspirin or an NSAID (non-steroidal anti-inflammatory drug).
Do not use this medication without first talking to your doctor if you drink more than three alcoholic beverages per day or if you have had alcoholic liver disease (cirrhosis). You may not be able to use acetaminophen.
Ask a doctor or pharmacist about using acetaminophen, aspirin, and caffeine if you have asthma or seasonal allergies, fever with a stiff neck, a stomach ulcer or pain, heartburn, a bleeding or blood clotting disorder, diabetes, or gout.
Do not use more of this medication than is recommended. An overdose of acetaminophen can cause serious harm. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day.
Stop using this medication and call your doctor at once if you have any symptoms of liver damage or bleeding in your stomach or intestines. Symptoms of liver damage include nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, and jaundice (yellowing of the skin or eyes). Symptoms of stomach bleeding include weakness or fainting, bloody or tarry stools, and coughing up blood or vomit that looks like coffee grounds.
Avoid drinking alcohol while you are taking this medication. Alcohol may increase your risk of stomach bleeding while taking aspirin, or liver damage while taking acetaminophen. Do not use any other over-the-counter cough, cold, allergy, pain, menstrual symptom, or fever medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”), aspirin, and caffeine are contained in many combination medicines. If you use certain products together you may accidentally use too much of a certain drug.
What should I discuss with my healthcare provider before taking Supac (acetaminophen, aspirin, and caffeine)?
Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye’s syndrome in children. You should not use this medication if you are allergic to acetaminophen (Tylenol), aspirin, or caffeine, or if you have:
-
a recent history of stomach or intestinal bleeding;
- liver disease;
-
asthma or severe allergic reaction caused by taking aspirin or an NSAID (non-steroidal anti-inflammatory drug), especially “aspirin triad syndrome”; or
-
if you are allergic to an NSAID such as Advil, Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others.
Ask a doctor or pharmacist if it is safe for you to take acetaminophen, aspirin, and caffeine if you have:
-
asthma or seasonal allergies;
-
fever with a stiff neck;
-
a stomach ulcer, heartburn, or stomach pain;
-
a bleeding or blood clotting disorder such as hemophilia;
-
diabetes; or
-
gout.
If you take acetaminophen, aspirin, and caffeine to treat headache pain, seek medical attention if you have:
-
a headache so bad you have to lie down;
-
a headache that causes vomiting;
-
what feels like the worst headache you’ve ever had;
-
a headache that seems different from your usual headaches;
-
a headache every day;
-
a headache after coughing, bending, exercising, or head injury;
-
if you have never had migraines diagnosed by a doctor; or
-
if you are having your first headache after age 50.
Aspirin may be harmful to an unborn baby’s heart, and may also reduce birth weight or have other dangerous effects. Tell your doctor if you are pregnant or plan to become pregnant while you are taking acetaminophen, aspirin, and caffeine. Aspirin, acetaminophen, and caffeine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I take Supac (acetaminophen, aspirin, and caffeine)?
Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger or smaller amounts, or use it for longer than recommended.
Do not use more of this medication than is recommended. An overdose of acetaminophen can cause serious harm. The maximum amount for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Using more acetaminophen could cause damage to your liver.
If you drink more than three alcoholic beverages per day, talk to your doctor before taking acetaminophen and never use more than 2 grams (2000 mg) per day.
Take this medication with a full glass of water. Take the medicine with food or milk if it makes your stomach upset. Stop using acetaminophen, aspirin, and caffeine and call your doctor if your symptoms do not improve, or if they get worse while taking this medication.
Acetaminophen can cause false results with some urine glucose tests. Talk to your doctor if you are diabetic and you notice changes in your glucose levels while taking this medication.
If you need to have any type of surgery, tell the surgeon ahead of time that you are taking aspirin. You may need to stop using the medicine for a short time.
Store acetaminophen, aspirin, and caffeine at room temperature away from heat and moisture.
What happens if I miss a dose?
Since this medication is often used only when needed, you may not be on a dosing schedule. If you are using the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.
The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.
An overdose of acetaminophen, aspirin, and caffeine can also cause ringing in your ears, headache, diarrhea, dizziness, restlessness, hallucinations, fast or slow heart rate, or seizure (convulsions).
What should I avoid while taking Supac (acetaminophen, aspirin, and caffeine)?
Avoid drinking alcohol while you are taking this medication. Alcohol may increase your risk of stomach bleeding while taking aspirin, or liver damage while taking acetaminophen. Do not use any other cough, cold, allergy, pain, menstrual symptom, or fever medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”), aspirin, and caffeine are contained in many combination medicines. If you use certain products together you may accidentally use too much of a certain drug. Read the label of any other medicine you are using to see if it contains acetaminophen, APAP, aspirin, or caffeine.
Avoid taking an NSAID such as ibuprofen (Motrin, Advil), diclofenac (Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.
Avoid coffee, tea, cola, energy drinks or other sources of caffeine while taking this medication. They can add to the side effects of the caffeine in the medication.
Supac (acetaminophen, aspirin, and caffeine) side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:
-
weakness or fainting;
-
black, bloody, or tarry stools;
-
coughing up blood or vomit that looks like coffee grounds;
-
severe nausea, vomiting, or stomach pain;
-
redness or swelling;
-
low fever with nausea, stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
-
fever lasting longer than 3 days;
-
pain lasting longer than 10 days; or
-
hearing problems, ringing in your ears.
Less serious side effects may include:
-
upset stomach, heartburn;
-
feeling nervous or excited; or
-
sleep problems (insomnia).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Supac (acetaminophen, aspirin, and caffeine)?
Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with aspirin may cause you to bruise or bleed easily.
Before taking acetaminophen, aspirin, and caffeine, tell your doctor if you are using any of the following drugs:
-
a blood thinner such as warfarin (Coumadin);
-
salicylates such as aspirin, Backache Relief Extra Strength, Novasal, Nuprin Backache Caplet, Doan’s Pills Extra Strength, Tricosal, and others; or
-
medication used to prevent blood clots, such as alteplase (Activase), clopidogrel (Plavix), dipyridamole (Persantine), ticlopidine (Ticlid), and urokinase (Abbokinase).
This list is not complete and there may be other drugs that can interact with acetaminophen, aspirin, and caffeine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Where can I get more information?
- Your pharmacist can provide more information about acetaminophen, aspirin, and caffeine.
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
- Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2006 Cerner Multum, Inc. Version: 3.01. Revision Date: 11/19/2009 2:34:59 PM.
Supartz
30/06/10
Generic Name: sodium hyaluronate (injectable) (SO dee um hi al yoo RON ayt)
Brand Names: Euflexxa, Hyalgan, Supartz
What is sodium hyaluronate?
Sodium hyaluronate is similar to the synovial (sin-OH-vee-ul) fluid that surrounds your joints. Synovial fluid acts as a lubricant and shock absorber.
Sodium hyaluronate is injected into the knee joint to treat pain caused by osteoarthritis. This medication is usually reserved for people whose pain has not been relieved by using other medicines or treatments.
Sodium hyaluronate may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about sodium hyaluronate?
You should not receive sodium hyaluronate if you have an infection of your knee joint, or infection of the skin around your knee.
Before receiving sodium hyaluronate, tell your doctor if you have an allergy to eggs, birds, or bird products.
Sodium hyaluronate is given as an injection into your knee. This medicine is usually given as one injection per week for a total of 3 weeks.
For the first 48 hours after your injection, avoid any strenuous or weight-bearing activity that lasts longer than 1 hour. This includes jogging, tennis, stair-climbing, or lifting weights. Follow your doctor’s instructions about other activity restrictions.
What should I discuss with my health care provider before receiving sodium hyaluronate?
You should not receive sodium hyaluronate if you have:
-
an infection of your knee joint; or
-
infection of the skin around your knee.
Before receiving sodium hyaluronate, tell your doctor if you have an allergy to eggs, birds, or bird products.
This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether sodium hyaluronate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How is sodium hyaluronate given?
Sodium hyaluronate is given as an injection into your knee. You will receive this injection in a doctor’s office or other clinic setting.
This medicine is usually given as one injection per week for a total of 3 weeks. Your doctor may want you to have injections more often than once each week.
What happens if I miss a dose?
Contact your doctor for instructions if you miss an appointment for your injection.
What happens if I overdose?
Seek emergency medical attention if you think you have received too much of this medicine. An overdose of sodium hyaluronate is not expected to produce life-threatening symptoms.
What should I avoid while receiving sodium hyaluronate?
For the first 48 hours after your injection, avoid any strenuous or weight-bearing activity that lasts longer than 1 hour. This includes jogging, tennis, stair-climbing, or lifting weights. Follow your doctor’s instructions about other activity restrictions.
Sodium hyaluronate side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Other less serious side effects are more likely to occur, such as:
-
pain or swelling where the medicine was injected;
-
joint pain;
-
headache;
-
numbness or tingly feeing;
-
skin irritation; or
-
knee pain or tenderness.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect sodium hyaluronate?
There may be other drugs that can affect sodium hyaluronate. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Where can I get more information?
- Your doctor or pharmacist has additional information about sodium hyaluronate written for health professionals that you may read.
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
- Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2006 Cerner Multum, Inc. Version: 1.05. Revision Date: 4/12/2009 4:43:24 PM.
Sunmark Loratadine
30/06/10
Generic Name: loratadine
Dosage Form: tablet, orally disintegrating
McKesson Loratadine Drug Facts
Active ingredient (in each tablet)
Loratadine 10 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat
Warnings
Do not use
if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
liver or kidney disease. Your doctor should determine if you need a different dose.
When using this product
do not take more than directed. Taking more than directed may cause drowsiness.
Stop use and ask a doctor if
an allergic reaction to this product occurs. Seek medical help right away.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- place 1 tablet on tongue; tablet disintegrates, with or without water
| adults and children 6 years and over | 1 tablet daily; not more than 1 tablet in 24 hours |
| children under 6 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
Other information
- Phenylketonurics: contains Phenylalanine 0.9 mg per tablet
- do not use if blister unit is broken or torn
- store between 20° to 25°C (68° to 77°F)
- use tablet immediately after opening individual blister
Inactive ingredients
anhydrous citric acid, artificial cherry flavor, aspartame, colloidal silicon dioxide, crospovidone, lactose monohydrate, mannitol, microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium stearate
Questions or comments?
1-800-719-9260
Principal Display Panel
Compare to Claritin® Reditabs® active ingredient
24 Hour
Allergy Relief
Loratadine
Orally Disintegrating Tablets, 10 mg
Antihistamine
For adults and children six years and older
Non-Drowsy*
Relief of sneezing, runny nose, itchy, watery eyes, itchy throat or nose
Melteez® Tablets Melts in Your Mouth
Actual Size
*When taken as directed. See Drug Facts Panel.
Loratadine Carton
| Sunmark Loratadine ALLERGY RELIEF loratadine tablet, orally disintegrating |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA075990 | 02/02/2004 | |
| Labeler - McKesson (177667227) |
Revised: 07/2009McKesson




