Label: ACETAMINOPHEN tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 21695-007-00, 21695-007-30, 21695-007-60, 21695-008-00, view more21695-008-14, 21695-008-15, 21695-008-20, 21695-008-30, 21695-008-50, 21695-008-60 - Packager: Rebel Distributors Corp
- This is a repackaged label.
- Source NDC Code(s): 51645-703, 51645-706
- 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 February 14, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- PURPOSE
- Keep Out of Reach of Children
- Uses
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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
- Other Information
- Inactive ingredients
- Principal Display Panel
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21695-007(NDC:51645-703) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (UNII: 68401960MK) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color WHITE Score no score Shape ROUND Size 12mm Flavor Imprint Code GPI;A325 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21695-007-30 30 in 1 BOTTLE 2 NDC:21695-007-60 60 in 1 BOTTLE 3 NDC:21695-007-00 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 01/01/2007 ACETAMINOPHEN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21695-008(NDC:51645-706) 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 CROSPOVIDONE (UNII: 68401960MK) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 14mm Flavor Imprint Code GPI;A5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21695-008-14 14 in 1 BOTTLE 2 NDC:21695-008-15 15 in 1 BOTTLE 3 NDC:21695-008-20 20 in 1 BOTTLE 4 NDC:21695-008-30 30 in 1 BOTTLE 5 NDC:21695-008-50 50 in 1 BOTTLE 6 NDC:21695-008-60 60 in 1 BOTTLE 7 NDC:21695-008-00 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 01/01/2007 Labeler - Rebel Distributors Corp (118802834) Establishment Name Address ID/FEI Business Operations Rebel Distributors Corp 118802834 RELABEL, REPACK
