Walgreens 44-678

Walgreens 44-678

Drug Labeling and Warnings

Drug Details

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PAIN RELIEVER REGULAR STRENGTH- acetaminophen tablet 
Walgreen Company

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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Walgreens 44-678

Active ingredient (in each gelcap)

Acetaminophen 325 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. The maximum daily dose of this product is 10 gelcaps (3,250 mg) in 24 hours. 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 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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
  • adults and children 12 years and over
    • take 2 gelcaps every 4-6 hours while symptoms last
    • do not take more than 10 gelcaps in 24 hours, unless directed by a doctor
    • do not take for more than 10 days unless directed by a doctor
  • children under 12 years: ask a doctor

Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid high humidity
  • use by expiration date on package

Inactive ingredients

corn starch, croscarmellose sodium, FD&C red # 40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, propylene glycol, shellac glaze, stearic acid, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

Well at
Walgreens

NDC: 0363-6780-20

REGULAR STRENGTH
Pain Reliever

Acetaminophen 325 mg /
Pain Reliever / Fever Reducer

225 GELCAPS
Fast-Release
Quick Gels™

Actual Size

Compare to Regular Strength Tylenol® active ingredient‡‡

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

‡‡This product is not manufactured or
distributed by McNeil Consumer
Healthcare, owner of the registered
trademark Regular Strength Tylenol®.

Walgreens Pharmacist Recommended.
Walgreens Pharmacist Survey Study,
November 2014.

50844   REV0515A67820   ORG0515-F_R02

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD, DEERFIELD, IL 60015
100%SATISFACTION GUARANTEED
walgreens.com  ©2016 Walgreen Co.

Walgreens 44-678

Walgreens 44-678

PAIN RELIEVER  REGULAR STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0363-6780
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorRED, WHITEScoreno score
ShapeOVALSize16mm
FlavorImprint Code LB
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0363-6780-20225 in 1 BOTTLE; Type 0: Not a Combination Product07/24/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34307/24/2015
Labeler - Walgreen Company (008965063)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(0363-6780)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837MANUFACTURE(0363-6780)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(0363-6780)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(0363-6780)

Revised: 2/2019
 
Walgreen Company


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