Your browser does not support JavaScript! ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN]
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ACETAMINOPHEN tablet, film coated, extended release
[Amerisource Bergen]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

ACTIVE INGREDIENT (IN EACH CAPLET)

Acetaminophen USP, 650 mg

PURPOSE

Pain reliever/fever reducer

USES

  • temporarily relieves minor aches and pains due to:
    • muscular aches
    • backache
    • headache
    • minor pain of arthritis
  • 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 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.
  • 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 a 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 and children 12 years and over ▪ 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
    children under 12 years ▪ do not use

OTHER INFORMATION

  • store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F).
  • see end panel for batch number and expiration date
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

INACTIVE INGREDIENTS

Croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

GOOD NEIGHBOR PHARMACY®

Compare to Tylenol®8 Hour active ingredient

NDC 46122-0062-71

Lasts up to 8 Hour

Use only as directed.

See New Warnings Information

acetaminophen extended-release tablets, USP 650 mg

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

Pain Reliever/Fever Reducer

  • For up to 8 Hour Relief of Minor Muscle Aches & Pain

50 caplets*650 mg EACH (*capsule-shaped tablets)

Distributed By: AmerisourceBergen

5095557/R0512

This is the 50 count bottle carton label for GNP Acetaminophen extended-release tablets, USP 650 mg.

ACETAMINOPHEN 
acetaminophen tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:46122-062
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
STARCH, PREGELATINIZED CORN 
PROPYLENE GLYCOL 
SODIUM LAURYL SULFATE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeOVAL (Capsule Shaped) Size19mm
FlavorImprint Code cor116
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46122-062-7150 in 1 BOTTLE
2NDC:46122-062-78100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07620004/30/2002
Labeler - Amerisource Bergen (007914906)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029manufacture(46122-062)

Revised: 10/2012
 
Amerisource Bergen

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