Your browser does not support JavaScript! ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [SELECT BRAND]
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RxNorm Names

ACETAMINOPHEN tablet, film coated, extended release
[Select Brand]


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:
    • minor pain of arthritis
    • muscular aches
    • backache
    • headache
    • toothache
    • the common cold
    • premenstrual and menstrual cramps
  • 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 have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets.
  • 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

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 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

select brand®

NDC 15127-332-24

Use only as directed.

ARTHRITIS PAIN RELIEF

See New Warnings Information

Non-Aspirin

AcetaminophenCaplets*650 mg Extended-Release Tablets, USP

24 Caplets* 650 mg each (*capsule-shaped tablets)

Pain Reliever/Fever Reducer

For the Temporary Relief of Minor Arthritis Pain

Lasts up to 8 hours

٭Compare to the active ingredient of TYLENOL®ARTHRITIS PAIN

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

Distributed by: SELECT BRAND DISTRIBUTORS

5095101/R0412

This is the 24 count blister carton label for Select Brand Acetaminophen extended-release tablets, USP 650 mg.
ACETAMINOPHEN 
acetaminophen tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:15127-332
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:15127-332-2424 in 1 BOTTLE
2NDC:15127-332-01100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07620004/30/2002
Labeler - Select Brand (043562370)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029manufacture(15127-332)

Revised: 10/2012
 
Select Brand

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