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Acetaminophen by Walgreen Company

Dosage form: tablet, extended release
Ingredients: ACETAMINOPHEN 650mg
Labeler: Walgreen Company
NDC Code: 0363-0340

Acetaminophen

Drug Facts

Active ingredient (in each geltab)

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 geltabs 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

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 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
  • the tablet got stuck in your throat

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 geltabs every 8 hours. Swallow only one geltab at a time.
  • take a sip of water before swallowing each geltab and wash each geltab down with water (up to a full 8 oz. glass).
  • swallow whole; do not crush, chew, split or dissolve
  • do not take more than 6 geltabs 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 high humidity.
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

Inactive ingredients

croscarmellose sodium, gelatin, glycerin, hypromellose, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, starch (corn), titanium dioxide

Questions?

call 1-800-406-7984

DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 650 mg Geltab Bottle Label

Walgreens

Compare to Tylenol® 8 HR
Arthritis Pain active ingredient††

EASY-OPEN

NDC 0363-0340-08

Arthritis Pain Reliever
ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP,
650 mg / PAIN RELIEVER / FEVER REDUCER

ARTHRITIS 8 HOUR

  • For the temporary relief of minor arthritis pain
  • Lasts up to 8 hours

ACTUAL SIZE

80 GELTABS* (*GELATIN-COATED TABLETS)

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

ACETAMINOPHEN 
acetaminophen tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0340
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
GELATIN, UNSPECIFIED 
GLYCERIN 
HYPROMELLOSE, UNSPECIFIED 
FERROSOFERRIC OXIDE 
FERRIC OXIDE YELLOW 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE, UNSPECIFIED 
PROPYLENE GLYCOL 
SODIUM LAURYL SULFATE 
TITANIUM DIOXIDE 
STARCH, CORN 
Product Characteristics
Colorwhite (White to Yellow) Scoreno score
ShapeROUNDSize13mm
FlavorImprint Code350
Contains    
Packaging
#Item CodePackage Description
1NDC:0363-0340-0880 TABLET, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07856905/01/2016
Labeler - Walgreen Company (008965063)
Registrant - Ranbaxy Pharmaceuticals Inc. (947890044)
Establishment
NameAddressID/FEIOperations
Ohm Laboratories Inc.184769029MANUFACTURE(0363-0340)

 
Walgreen Company

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Medically reviewed on Aug 15, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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