LOW DOSE ASPIRIN- aspirin tablet, chewable

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)
Available from:
Walgreen Company
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
 Pain reliever for the temporary relief of minor aches and pains or as recommended by your doctor
Authorization status:
OTC monograph not final
Authorization number:
0363-0397-07

LOW DOSE ASPIRIN- aspirin tablet, chewable

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.

----------

Walgreens 44-397

Active ingredient (in each chewable tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor

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

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

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

or others]

take more or for a longer time than directed

Do not use

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

for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

if you have ever had an allergic reaction to this product or any of its ingredients

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

an allergic reaction occurs. Seek medical help right away.

you experience any of the following signs of stomach bleeding:

vomit blood

have bloody or black stools

feel faint

have stomach pain that does not get better

ringing in the ears or a loss of hearing occurs

pain gets worse or lasts more than 10 days

redness or swelling is present

new symptoms occur

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 (1-800-222-1222) right away.

Directions

drink a full glass of water with each dose

chew or crush tablets completely before swallowing; do not swallow tablets whole

adults and children 12 years and over: take 4 to 8 chewable tablets every 4 hours not to exceed 48

chewable tablets in 24 hours unless directed by a doctor

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

Other information

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

see end flap for expiration date and lot number

Inactive ingredients

corn starch, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, flavor,

maltodextrin, sucralose

Principal Display Panel

VALUE SIZE

NDC 0363-0397-07

Walgreens

Compare to Bayer

Chewable Low Dose Aspirin active ingredient††

Aspirin 81

81 mg CHEWABLE TABLETS

PAIN RELIEVER (NSAID)

CHEWABLE

LOW DOSE

HEART

HEALTH

108

CHEWABLE

TABLETS

(3 BOTTLES: 36 TABLETS PER BOTTLE)

ACTUAL SIZE

CHERRY FLAVOR

Chew or crush tablets completely before swallowing. Do not swallow tablets whole.

**Talk to your doctor or other healthcare provider before using this product for your heart.

Walgreens Pharmacist Survey

This product is not manufactured or distributed by Bayer AG, owner of the registered trademark

Bayer

Chewable Low Dose Aspirin.

50844 REV1118A39707

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

BROKEN OR MISSING

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com

©2018 Walgreen Co.

®

††

4 4 -397A

LOW DOSE ASPIRIN

aspirin tablet, chewable

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 36 3-0 39 7

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ASPIRIN (UNII: R16 CO5Y76 E) (ASPIRIN - UNII:R16 CO5Y76 E)

ASPIRIN

8 1 mg

Inactive Ingredients

Ingredient Name

Stre ng th

D&C RED NO . 2 7 (UNII: 2LRS18 5U6 K)

D&C RED NO . 3 0 (UNII: 2S42T28 0 8 B)

DEXTRATES (UNII: G26 3MI44RU)

STARCH, CO RN (UNII: O8 232NY3SJ)

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

Product Characteristics

Color

PINK

S core

no sco re

S hap e

ROUND

S iz e

8 mm

Flavor

CHERRY

Imprint Code

44;39 7

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Marketing End

Walgreen Company

#

Item Code

Package Description

Date

Date

1

NDC:0 36 3-0 39 7-

3 in 1 CARTON

0 9 /0 4/20 0 1

1

36 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part343

0 9 /0 4/20 0 1

Labeler -

Walgreen Company (008965063)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(0 36 3-0 39 7)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(0 36 3-0 39 7)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(0 36 3-0 39 7)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

PACK(0 36 3-0 39 7)

Revised: 5/2020

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