ACETAMINOPHEN- acetaminophen tablet, film coated 
Walgreens 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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ACETAMINOPHEN

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

Liver warning

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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 ever had an allergic reaction to this product or any of its ingredients.

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. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

Do not take more than directed.

SEE OVERDOSE WARNING.

adults & children 12 years of age and over
  • take 2 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets in 24 hours, unless directed by doctor
  • do not take more than 10 days, unless directed by a doctor
children under 12 years of age
  • ask a doctor

Other information

Inactive ingredients

hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions or comments?

call 1 (888) 577-8033

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

PRINCIPAL DISPLAY PANEL - 30 Caplet Bottle Carton

BONUS SIZE | 24 + 6 FREE
NDC 0363-0143-03

Walgreens

Compare to Tylenol® Extra Strength
Caplets active ingredient††

Pain Reliever
ACETAMINOPHEN 500 mg / PAIN RELIEVER / FEVER REDUCER

EXTRA STRENGTH
CAPLETS

30 CAPLETS

ACTUAL SIZE

PRINCIPAL DISPLAY PANEL - 30 Caplet Bottle Carton
ACETAMINOPHEN 
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0143
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
hypromellose, unspecified (UNII: 3NXW29V3WO)  
magnesium stearate (UNII: 70097M6I30)  
microcrystalline cellulose (UNII: OP1R32D61U)  
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
povidone, unspecified (UNII: FZ989GH94E)  
stearic acid (UNII: 4ELV7Z65AP)  
talc (UNII: 7SEV7J4R1U)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize17mm
FlavorImprint Code S500
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0143-031 in 1 CARTON04/01/2020
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0363-0143-061 in 1 CARTON04/01/2020
260 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34304/01/2020
Labeler - Walgreens Co. (008965063)

Revised: 5/2022
Document Id: 35c4aea6-6726-4d18-b6d1-5df6bc5e76bb
Set id: e87e5993-4ea7-4c27-89c4-1b81a6b673c0
Version: 2
Effective Time: 20220506
 
Walgreens Co.