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 Rebel Distributors Corp. 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
Acetaminophen 325mg
Acetaminophen 500mg
Keep Out Of Reach Of Children
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose get medical help or contact a Poison Control Center immediately. Quick medical attention is critical for adults as well as children, even if you do not notice symptoms or signs.
Uses
Use for temporary relief of minor aches and pains due to:
° headache ° muscular aches ° backache ° arthritis ° the common cold ° toothache ° menstrual cramps ° temporarily reduces fever
Warnings
Alcohol Warning: If you consume 3 or more alcoholic beverages every day, ask your doctor whether you should take Acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.
Do not use with any other product containing Acetaminophen or if you have ever had an allergic reaction to pain relievers/fever reducers.
Stop use and ask a doctor if
° new symptoms occur ° redness or swelling is present ° pain gets worse or lasts more than 10 days ° fever gets worse or lasts more than 3 days.
If pregnant or breast-feeding, ask a doctor before use.
Directions
Do not take more than directed
° adults and children 12 years and older, take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours. ° children under 12, consult a doctor before use.
Other Information
For your protection, this bottle has an imprinted Safety Seal under cap. Do not use if Safety Seal is broken or missing.
Store at room temperature.
Questions? To report an adverse drug effect, contact 1-800-795-9775.
Inactive Ingredients
Crospovidone, Povidone, Pregelatinized Starch, Stearic Acid.
Distributed by:
Plus PharmaCommack
New York 11725
Repackaged by:
Rebel Distributors Corp
Thousand Oaks, CA 91320
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