FDA Label for Acetamiophen
View Indications, Usage & Precautions
Acetamiophen Product Label
The following document was submitted to the FDA by the labeler of this product Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Active Ingredients (In each caplet)
| Active ingredient (in each caplet) | Purpose |
| Acetaminophen 650 mg | Pain reliever/fever reducer |
Otc - Purpose
Drug Facts
Active ingredient (in each caplet)
Acetaminophen 650mg ....................... Pain reliever/fever reducer.
Uses
- temporarily relieves minor aches and pain due to:
- muscular aches
- backache
- minor pain of arthritis
- toothache
- premenstrual and menstrual cramps
- headache
- the common cold
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product.
- skin reddening
- blisters
- rash.
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Do Not Use
- with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- If you are allergic to acetaminophen or any of the inactive ingredients in this product.
Otc - Ask Doctor
Ask a doctor before use if you have liver disease.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Stop Use And Ask A Doctor If
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling if present.
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poision Control of Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs of symptoms.
Directions
- do not take more than directed (see overdose warning)
- take 2 caplets every 8 hours with water
- swallow whole; do not crush, chew, split or dissolve
- do not take more than 6 caplets in 24 hours
- do not use for more than 10 days unless directed by a doctor
- do not use
Adults and children 12 years and over:
Children under 12 years:
Other Information
- store between 20-25°C (68-77°F)
- do not use if foil inner seal imprinted with "SAFETY SEAL" is broken or missing.
Inactive Ingredients
hydroxyethyl cellulose, maize starch, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium lauryl sulfate, FD&C yellow no. 6 aluminum lake and FD&C yellow no. 10 aluminum lake.
Questions Or Comments?
Call: 1.866.901.DRUG (3784) (toll-free)
Manufactured for
Heritage Pharmaceuticals Inc.,
Eatontown, NJ 07724
1.866.901.DRUG (3784)
Made in India
Rev.08/16
* Please review the disclaimer below.