Label: ACETAMINOPHEN tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 52204-114-99 - Packager: Cispharma, Inc
- 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 March 28, 2011
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- Official Label (Printer Friendly)
- Drug Facts
- PURPOSE
- Uses
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Warnings
Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers or fever reducers. Acetaminophen may cause liver damage.
- Overdose Warning:
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Directions: do not take more than directed (see overdose warning)
adults and children 12 years and over
- take 2 tablets every 4 to 6 hours while symptoms last
- if needed, tablets may be crushed and should be taken immediately. Take the entire dose for best results. Crushing the tablets will result in bitter taste.
- do not take more than 8 tablets in 24 hours
- do not use more than 10 days unless directed by a doctor
children under 12 years
- do not use this adult product in children under 12 years of age: this will provide more than the recommended dose (overdose) and may cause liver damage.
- Other Information
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52204-114 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) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color WHITE (White) Score 2 pieces Shape ROUND (round) Size 12mm Flavor Imprint Code MLX;152 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52204-114-99 35587 in 1 DRUM Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 03/28/2011 Labeler - Cispharma, Inc (833171445) Registrant - Cispharma, Inc (833171445) Establishment Name Address ID/FEI Business Operations Cispharma, Inc 833171445 manufacture