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NDC 57896-0268-01 ACETAMINOPHEN 650 mg/1 Details

ACETAMINOPHEN 650 mg/1

ACETAMINOPHEN is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by GERI-CARE PHARMACEUTICAL CORP. The primary component is ACETAMINOPHEN.

MedlinePlus Drug Summary

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 57896-0268-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	57896-0268
Product ID	57896-268_92c22593-dafa-20a8-e053-2a95a90a365d
Associated GPIs	64200010000420
GCN Sequence Number	022123
GCN Sequence Number Description	acetaminophen TABLET ER 650 MG ORAL
HIC3	H3E
HIC3 Description	ANALGESIC/ANTIPYRETICS,NON-SALICYLATE
GCN	16910
HICL Sequence Number	001866
HICL Sequence Number Description	ACETAMINOPHEN
Brand/Generic	Generic
Proprietary Name	ACETAMINOPHEN
Proprietary Name Suffix	n/a
Non-Proprietary Name	ACETAMINOPHEN
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	650
Active Ingredient Units	mg/1
Substance Name	ACETAMINOPHEN
Labeler Name	GERI-CARE PHARMACEUTICAL CORP
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA211544
Listing Certified Through	2024-12-31

Package

Package Images

NDC 57896-0268-01 (57896026801)

Pricing Information	N/A
NDC Package Code	57896-268-01
Billing NDC	57896026801
Package	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (57896-268-01)
Marketing Start Date	2019-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 92c22593-daf9-20a8-e053-2a95a90a365d Details

ACTIVE INGREDIENT (IN EACH CAPLET)

Acetaminophen USP, 650 mg

PURPOSE

Pain reliever/fever reducer

USES

• temporarily relieves minor aches and pains due to:

• minor pain of arthritis

• muscular aches

• backache

• premenstrual and menstrual cramps

• the common cold

• headache

• toothache

• temporarily reduces fever

WARNINGS

Liver warning: This product contains acetaminophen. Severe Liver damage may occur if you take

• more than 6 caplets in 24 hours, which is the maximum daily amount

• with other drugs containing acetaminophen

• 3 or more alcoholic drinks everyday while using this product

Allergy alert: acetaminophen may cause severe skin reactions

Symptoms may include:

• skin reddening

• blisters

• rash

If a skin reaction occurs, stop use and seek medical help right away

Do not use

• with any other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

• if you are allergic to acetaminophen or any of the inactive ingredients in this product.

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 doctor if

• pain gets worse or lasts more than 10 days

• fever gets worse or lasts more than 3 days

• new symptoms 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.

Keep out of reach of children

Overdose warning: In case of overdose, get medical help or contact a poison control center right away.(1-800 222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

DIRECTIONS

• do not take more than directed (see overdose warning)

Adults: • take 2 caplets every 8 hours with water

• swallow whole; do not crush, chew, split or dissolve

• do not take more than 6 caplets in 24 hours

• do not use for more than 10 days unless directed by a doctor

Under 18 years of age: ask a doctor

OTHER INFORMATION

• store between 20-25°C (68-77°F)

INACTIVE INGREDIENTS

hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

QUESTIONS OR COMMENTS ?

1-800-540-3765

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN

acetaminophen tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57896-268
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg

Ingredient Name	Strength
Inactive Ingredients
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	G650
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57896-268-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA211544	07/01/2019

Labeler - GERI-CARE PHARMACEUTICAL CORP (611196254)

Registrant - GERI-CARE PHARMACEUTICAL CORP (611196254)

Revised: 9/2019

Document Id: 92c22593-dafa-20a8-e053-2a95a90a365d

Set id: 92c22593-daf9-20a8-e053-2a95a90a365d

Version: 1

Effective Time: 20190917