NDC | 57896-221-01, 57896-221-05, 57896-221-10, 57896-221-25 |
Set ID | ae00015d-5e5f-4099-ba03-b20bf45ed374 |
Category | HUMAN OTC DRUG LABEL |
Packager | Geri-Care Pharmaceutical Corp |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- Active ingredient
- Purpose
- Uses
- Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 caplets 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 aretaking 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.
Close - Directions
- do not take more than directed
- adults and children 12 years and over: take 1-2 caplets every 4-6 hours, as needed; not more than 8 caplets in 24 hours
- children under 12 years: ask a doctor
- Other Information
- TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
- store at 20⁰C-25⁰C (68⁰F-77⁰F)
- for institutional use only
Inactive ingredients
povidone, sodium starch glycolate, starch, stearic acid. May also contain: crospovidone, methylparaben and probylparaben
- Package label
GERICARE
NDC 57896-221-01
Non-Aspirin
Extra Strength
PAIN RELIEF
Acetaminophen Caplets
Pain Reliever / Fever Reducer
Compare to active ingredients in Extra Strength Tylenol Caplets*
PACKAGE NOT CHILD RESISTANT
100 Caplets 500 mg each
- INGREDIENTS AND APPEARANCE
EXTRA STRENGTH PAIN RELIEF
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-221 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) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) CROSPOVIDONE (UNII: 68401960MK) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Product Characteristics Color white (WHITE) Score no score Shape CAPSULE (Capsule) Size 15mm Flavor Imprint Code M2A457344 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57896-221-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2011 2 NDC:57896-221-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2011 3 NDC:57896-221-05 50 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2013 4 NDC:57896-221-25 250 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2017 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(57896-221)