Label: ACETAMINOPHEN tablet, coated
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Contains inactivated NDC Code(s)
NDC Code(s): 53598-003-01, 53598-003-10 - Packager: Bonita Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 2, 2013
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Purposes
- Uses
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Warnings
Liver warning:
This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000mg) in 24 hours. Severe liver damage may occur if you take
- more than 4,000mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). 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
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 is pressent
These could be signs of a serious condition.
Overdose warning:
Taking more than the 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.
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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 in 24 hours unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor
Children under 12years: ask a doctor
- Other Information
- Inactive Ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53598-003 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength POVIDONE (UNII: FZ989GH94E) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape OVAL ((Capsule Shaped Tablets)) Size 17mm Flavor Imprint Code GPI;A5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53598-003-01 100 in 1 BOTTLE, PLASTIC 2 NDC:53598-003-10 1000 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/02/2013 Labeler - Bonita Pharmaceuticals LLC (004219442) Registrant - Bonita Pharmaceuticals LLC (004219442) Establishment Name Address ID/FEI Business Operations Bonita Pharmaceuticals LLC 004219442 label(53598-003)
