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.

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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
muscle pain
menstrual 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
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 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
•Sodium & Caffeine Free

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 Bayer AG, owner of
the registered trademark Genuine Bayer® Aspirin. 50844 REV0318B15712

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007
©TOPCO LNKA0521 QUESTIONS? 1-888-423-0139
topcare@topco.com www.topcarebrand.com

Visit here for more information:
http://topbrnds.com/48ZZSQ

TopCare 44-157

ASPIRIN
aspirin tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-157
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	44;157;ASPIRIN
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-157-12	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/10/1996
2	NDC:36800-157-87	1 in 1 CARTON	02/10/1996
2		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:36800-157-17	300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/10/1996
4	NDC:36800-157-14	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/10/1996

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	02/10/1996

Labeler - Topco Associates, LLC (006935977)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	manufacture(36800-157)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(36800-157)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(36800-157)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(36800-157)

Revised: 9/2021

Document Id: f1c2dbae-9fc2-41ea-b672-41824b69a5d7

Set id: 5f32cf74-dbea-496c-ba23-2040ea354f40

Version: 7

Effective Time: 20210928

Topco Associates, LLC