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 Velocity Pharma. 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 500mg
Purpose
pain reliever/fever reducer
Uses
- temporarily reduces fever
Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks everyday while using this product
- with any other drug containing acetaminophen (prescription or not prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- If you have ever had an allergic reaction to acetaminophen or any of the inactive ingredients in this product.
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms appear
these could be signs of a serious condition
do not use
ask a doctor before use if you have liver disease
ask your doctor or pharmacist before use if you are 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.
Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control 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 or symptoms.
Directions
- do not take more than directed (see overdose warning).
- Adults and children 12 years and over:
- take 2 caplets every 6 hours while symptoms last.
- do not take more than 6 caplets of this product in 24 hours, unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor
children under 12 years:
- Ask a doctor
Other Information
- Store at a controlled temperature between 62° and 77 °F)
Inactive Ingredients
P.G Starch, P.V.P.K.30, sodium metabisulfite, colloidal silicon dioxide, Hypromellose-15, Microcrystalline Cellulose, Croscarmellose Sodium, Stearic Acid, Sodium Starch Glycolate, Hypromellose-6, Polyethylene Glycol, Titanium Dioxide.
Questions Or Comments
Questions? 1-855-314-1850
Package Label.Principal Display Panel
NDC: 76168-010 -12 100 COUNT
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