Label: ACETAMINOPHEN tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 52959-002-10, 52959-002-14, 52959-002-15, 52959-002-20, view more52959-002-24, 52959-002-25, 52959-002-30, 52959-002-40, 52959-002-42, 52959-002-45, 52959-002-50, 52959-002-90 - Packager: H.J. Harkins Company, 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 September 5, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take
more than 8 tablets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this productDo 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.
Ask a doctor before use if you have
liver disease.
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin.
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 symptom occur
redness or swelling is presentThese could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Keep out of reach of children.
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52959-002 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 STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Product Characteristics Color white Score no score Shape ROUND Size 12mm Flavor Imprint Code M2A457344 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52959-002-10 10 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2001 2 NDC:52959-002-14 14 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2001 3 NDC:52959-002-15 15 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2001 4 NDC:52959-002-20 20 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2001 5 NDC:52959-002-24 24 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2001 6 NDC:52959-002-25 25 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2001 7 NDC:52959-002-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2001 8 NDC:52959-002-40 40 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2001 9 NDC:52959-002-42 42 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2001 10 NDC:52959-002-45 45 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2001 11 NDC:52959-002-50 50 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2001 12 NDC:52959-002-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2001 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 10/08/2001 Labeler - H.J. Harkins Company, Inc. (147681894) Establishment Name Address ID/FEI Business Operations H.J. Harkins Company, Inc. 147681894 manufacture(52959-002) , relabel(52959-002) , repack(52959-002)
