ASPIRIN 81 MG LOW DOSE- aspirin tablet, coated

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

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Active ingredient:
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)
Available from:
Meijer Distribution Inc
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. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
Authorization status:
OTC monograph not final
Authorization number:
41250-600-14, 41250-600-32, 41250-600-98

ASPIRIN 81 MG LOW DOSE- aspirin tablet, coated

Meijer Distribution Inc

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.

----------

Meijer 44-600A

Active ingredient (in each 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. Because of its

delayed action, this product will not provide fast relief of headaches or other symptoms needing

immediate relief.

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

asthma (wheezing)

shock

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

Do not use

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

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:

feel faint

have bloody or black stools

vomit blood

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

adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24

hours unless directed by a doctor

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

Other information

use by expiration date on package

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

Inactive ingredients

corn starch, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline

cellulose, polydextrose, polyethylene glycol, shellac wax, silica, simethicone, sodium bicarbonate,

sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

1-800-426-9391

Principal Display Panel

NDC 41250-600-14

Compare to Bayer® Low Dose Aspirin active ingredient

meijer®

aspirin 81 mg

Pain Reliever (NSAID)

Low

Dose

Safety Coated | Aspirin Regimen

500 Enteric Coated Tablets

Actual

Size

Talk to your doctor or other healthcare provider

before using this product for your heart.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY

SEAL UNDER CAP IS BROKEN OR MISSING

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

trademark Bayer® Low Dose Aspirin. 50844 REV0318B60014

DIST. BY MEIJER

DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

Meijer 4 4 -600

ASPIRIN 81 MG LOW DOSE

aspirin tablet, coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:41250 -6 0 0

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

STARCH, CO RN (UNII: O8 232NY3SJ)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

METHACRYLIC ACID (UNII: 1CS0 2G8 6 56 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PO LYDEXTRO SE (UNII: VH2XOU12IE)

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TRIACETIN (UNII: XHX3C3X6 73)

TRIETHYL CITRATE (UNII: 8 Z9 6 QXD6 UM)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

SHELLAC (UNII: 46 N10 7B71O)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

WATER (UNII: 0 59 QF0 KO0 R)

Product Characteristics

Color

YELLOW

S core

no sco re

S hap e

ROUND

S iz e

6 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:41250 -6 0 0 -32

1 in 1 CARTON

0 5/0 1/20 11

0 3/29 /20 19

1

120 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:41250 -6 0 0 -9 8

2 in 1 CARTON

0 5/0 1/20 11

2

36 5 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:41250 -6 0 0 -14

50 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 5/0 1/20 11

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 5/0 1/20 11

Labeler -

Meijer Distribution Inc (006959555)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(41250 -6 0 0 )

Meijer Distribution Inc

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

MANUFACTURE(41250 -6 0 0 ) , PACK(41250 -6 0 0 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(41250 -6 0 0 )

Revised: 4/2020

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