FDA Label for Acetaminophen
View Indications, Usage & Precautions
Acetaminophen Product Label
The following document was submitted to the FDA by the labeler of this product Advance Pharmaceutical 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.
Active Ingredient
(in each tablet)
Acetaminophen 325 mg
Purpose
Pain Reliever / Fever Reducer
Uses
temporarily reduces fever and relieves minor aches and pains caused by
- common cold
- headache
- toothache
- muscular aches
- premenstrual and menstrual cramps
Warnings
Liver warning: this product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
- child takes more than 5 tablets in 24 hours, which is the maximum daily amount
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
- adult’s pain gets worse or lasts more than 10 days
- child’s pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- any new symptoms appear
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.
Ask a doctor before use if the user has liver disease
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin
Stop use and ask a doctor if
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. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
Directions
| adults and children 12 years and over | 1-2 tablets every 4 hours or 2-3 tablets every 6 hours while symptoms last, not more than 12 tablets in 24 hours |
| children 6 to 11 years | 1 tablet every 4 hours while symptoms last, not more than 5 tablets in 24 hours |
| children under 6 years | ask a doctor |
Other Information
store at 15-30 °C (59-86 °F)
For Bulk package: This is a bulk package, dispense contents with a child-resistant closure in a tight, light resistant container as defined in the USP.
Inactive Ingredients
polyvinylpyrrolidone, pregelatinized corn starch, sodium starch glycolate, stearic acid
Questions Or Comments
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742
Package Label.Principal Display Panel
NDC: 17714-012-01 – 100 COUNT
NDC: 17714-012-10 – 1000 COUNT
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