NDC | 57896-200-01, 57896-200-05, 57896-200-06 |
Set ID | 5f0fdbc8-bc1d-5df8-e053-2a91aa0ab27d |
Category | HUMAN OTC DRUG LABEL |
Packager | Geri-Care Pharmaceutical Corp |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- Active Ingredients
- Purpose
- Uses
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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 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.
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 present
These 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.
- Directions
- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH PAIN RELIEF
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-200 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 (UNII: 68401960MK) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Product Characteristics Color white (WHITE) Score no score Shape ROUND (Round) Size 12mm Flavor Imprint Code M2A457344 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57896-200-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2012 2 NDC:57896-200-06 60 in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2014 3 NDC:57896-200-05 50 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 01/01/1989 Labeler - Geri-Care Pharmaceutical Corp (611196254) Registrant - Geri-Care Pharmaceutical Corp (611196254) Establishment Name Address ID/FEI Business Operations Geri-Care Pharmaceutical Corp 611196254 repack(57896-200)