REGULAR STRENGTH ASPIRIN- aspirin and caffeine tablet, film coated 
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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Walgreens 44-164-Delisted

Active ingredients

Aspirin (NSAID)*400 mg

Caffeine 32 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever aid

Uses

  • temporarily relieves minor aches and pains due to:

    • headache

    • a cold

    • muscular aches

    • toothache

    • arthritis

    • menstrual cramps

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye"s syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

  • hives

  • facial swelling

  • shock

  • asthma (wheezing)

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • are age 60 or older

  • have had stomach ulcers or bleeding problems

  • take a blood thinning (anticoagulant) or steroid drug

  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]

  • have 3 or more alcoholic drinks every day while using this product

  • take more or for a longer time than directed

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer

Ask a doctor before use if

  • stomach bleeding warning applies to you

  • you have a history of stomach problems, such as heartburn

  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

  • you have asthma

  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

  • gout

  • diabetes

  • arthritis

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:

  • feel faint

  • have bloody or black stools

  • vomit blood

  • have stomach pain that does not get better

  • an allergic reaction occurs. Seek medical help right away.

  • new symptoms occur

  • redness or swelling is present

  • ringing in the ears or loss of hearing occurs

  • pain gets worse or lasts more than 10 days

  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • do not use more than directed

  • drink a full glass of water with each dose

  • adults and children 12 years of age and over: take 2 tablets every 6 hours; not more than 8 tablets in 24 hours, or as directed by a doctor

  • children under 12 years: do not use unless directed by a doctor

Other information

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

  • see end flap for expiration date and lot number

Inactive ingredients

hypromellose, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate

Questions or comments?

1-800-426-9391

Principal Display Panel

Walgreens

NDC 0363-0164-12

Compare to the active ingredients in Anacin®†

ASPIRIN PLUS CAFFEINE

Aspirin 400 mg, Caffeine 32 mg

Pain Reliever (NSAID)

Pain Reliever Aid

100 COATED TABLETS

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

†This product is not manufactured or distributed by Insight Pharmaceuticals Corp., owners of the registered trademark Anacin®.

50844 ORG031016417

Distributed by: Walgreen Co.

200 WILLMOT RD., DEERFIELD, IL 60015

©2010 Walgreen Co.

ITEM 147449

164-12

164-12

REGULAR STRENGTH ASPIRIN 
aspirin and caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0164
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN400 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE32 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code 44;164
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0164-121 in 1 CARTON
1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34301/01/201106/18/2018
Labeler - WALGREEN CO. (008965063)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(0363-0164)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(0363-0164)

Revised: 6/2015
Document Id: 6dc62a46-e339-439c-95a6-9245847ef64a
Set id: f43685f0-d7f4-40b9-9de4-1ee272e7b085
Version: 2
Effective Time: 20150618
 
WALGREEN CO.