ASPIRIN tablet, film coated

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

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Active ingredient:
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)
Available from:
Topco Associates, LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer temporarily relieves: - minor pain of arthritis - headache - menstrual pain - muscle pain - toothache - pain and fever of colds
Authorization status:
OTC monograph not final
Authorization number:
36800-157-12, 36800-157-14, 36800-157-17, 36800-157-87

ASPIRIN- aspirin tablet, film coated

Topco Associates, LLC

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.

----------

TopCare 44-157

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves:

minor pain of arthritis

headache

menstrual pain

muscle pain

toothache

pain and fever of colds

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:

facial swelling

shock

hives

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

take a blood thinning (anticoagulant) or steroid drug

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

have had stomach ulcers or bleeding problems

take more or for a longer time than directed

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

or others]

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

you are taking a diuretic

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

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

vomit blood

have bloody or black stools

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

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. 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 1 or 2 tablets every 4 hours or 3 tablets every 6 hours,

not to exceed 12 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

use by expiration date on package

Inactive ingredients

corn starch, hypromellose, polyethylene glycol, propylene glycol

Questions or comments?

1-888-423-0139

Principal display panel

TopCare

health

NDC 36800-157-12

COMPARE TO GENUINE BAYER ASPIRIN

ACTIVE INGREDIENT†

REGULAR STRENGTH

Aspirin 325 mg

PAIN RELIEVER FEVER REDUCER

(NSAID)

Safe Pain Relief Easy to Swallow

Sodium & Caffeine Free

100 COATED TABLETS

OUR PHARMACISTS RECOMMEND

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007

©TOPCO LNKA0818 QUESTIONS? 1-888-423-0139

topcare@topco.com www.topcarebrand.com

Visit here for more information:

http://topbrnds .com/48ZS2N

†This product is not manufactured or distributed by

Bayer HealthCare LLC, owner of the registered trademark

Genuine Bayer® Aspirin.

50844 REV0318A15712

4 4 - 157

ASPIRIN

aspirin tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:36 8 0 0 -157

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

325 mg

Inactive Ingredients

Ingredient Name

Stre ng th

STARCH, CO RN (UNII: O8 232NY3SJ)

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

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

Topco Associates, LLC

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

ROUND

S iz e

10 mm

Flavor

Imprint Code

44;157;ASPIRIN

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:36 8 0 0 -157-8 7

1 in 1 CARTON

0 2/10 /19 9 6

1

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:36 8 0 0 -157-12

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 2/10 /19 9 6

3

NDC:36 8 0 0 -157-14

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

0 2/10 /19 9 6

4

NDC:36 8 0 0 -157-17

30 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 2/10 /19 9 6

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 2/10 /19 9 6

Labeler -

T opco Associates, LLC (006935977)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

MANUFACTURE(36 8 0 0 -157)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(36 8 0 0 -157)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

PACK(36 8 0 0 -157)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(36 8 0 0 -157)

Revised: 4/2020

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