ACETAMINOPHEN- acetaminophen tablet, extended release 
GERI-CARE PHARMACEUTICAL CORP

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hst 265 (268)

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

1

ACETAMINOPHEN 
acetaminophen tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-268
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code G650
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57896-268-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21154407/01/2019
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
 
GERI-CARE PHARMACEUTICAL CORP