EXTRA STRENGTH NON-ASPIRIN PAIN RELIEVER- acetaminophen tablet 
WALGREEN CO.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredients

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:

  • headache

  •  the common cold

  • backache

  • minor pain of arthritis

  • toothache

  • muscular aches

  • premenstrual and menstrual cramps

  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 8 tablets 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.

Ask a doctor before use if you are

  • 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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. 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 tablets every 4 to 6 hours while symptoms last

  • do not take more than 8 tablets in 24 hours

  • do not take for more than 10 days unless directed by a doctor

  • children under 12 years: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage

Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number

Inactive ingredients

povidone, pregelatinized starch, stearic acid

Product Packaging

 Walgreens

NDC 0363-0148-01

Compare to Panadol® Extra Strength Tablets active ingredient†

Extra Strength

WAL-NADOL

ACETAMINOPHEN

Pain reliever/Fever Reducer

SEE NEW WARNINGS INFORMATION

30 TABLETS - 500 mg each

TABLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED  SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844    REV0709E14801

Distributed by: Walgreen Co.,

200 Wilmot Rd., Deerfield, IL 60015-4616

Product Packaging



EXTRA STRENGTH NON-ASPIRIN PAIN RELIEVER 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0148
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE 
STEARIC ACID 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize13mm
FlavorImprint Code 44;148
Contains    
Packaging
#Item CodePackage Description
1NDC:0363-0148-011 in 1 CARTON
130 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34301/21/1993
Labeler - WALGREEN CO. (008965063)

Revised: 05/2011
Document Id: cf21c5a2-1658-45c5-8bad-7641b605b0ed
Set id: a4c40c16-7f03-4148-aa57-acf626e0d8cd
Version: 4
Effective Time: 20110506
 
WALGREEN CO.