ACETAMINOPHEN- acetaminophen tablet, extended release 
Walgreen Company

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Acetaminophen

Drug Facts

Active ingredient (in each geltab)

Acetaminophen USP, 650 mg

Purpose

Pain reliever/fever reducer

Uses

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

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

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

ACTUAL SIZE

80 GELTABS* (*GELATIN-COATED TABLETS)

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

PRINCIPAL DISPLAY PANEL - 650 mg Geltab Bottle Label
ACETAMINOPHEN 
acetaminophen tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0340
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Colorwhite (White to Yellow) Scoreno score
ShapeROUNDSize13mm
FlavorImprint Code 350
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0340-0880 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2016
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/FEIBusiness Operations
Ohm Laboratories Inc.184769029MANUFACTURE(0363-0340)

Revised: 8/2018
Document Id: 1bc5ce72-38f4-43f7-99cc-2b8b4725e15b
Set id: a1cec332-5802-4684-8b7f-6cb98da40e8b
Version: 4
Effective Time: 20180815
 
Walgreen Company