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Topcare Aspirin

Package insert / prescribing information
Generic name: aspirin
Dosage form: tablet, chewable
Drug classes: Platelet aggregation inhibitors, Salicylates

Medically reviewed by Drugs.com. Last updated on Mar 22, 2022.

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.

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

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 have ever had an allergic reaction to any other pain reliever/fever reducer
for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

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 are taking a diuretic
you have asthma

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

diabetes
gout
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
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days
redness or swelling is present
new symptoms occur
ringing in the ears or loss of hearing occurs

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 (1-800-222-1222).

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: consult a doctor

Other information

store at 20-25°C (68-77°F)

Inactive ingredients

corn starch, dextrose excipient, FD&C yellow no. 6 aluminum lake, flavors, saccharin sodium

Questions or comments?

1-888-423-0139

Principal Display Panel

COMPARE TO BAYER® CHEWABLE ASPIRIN ACTIVE INGREDIENT

LOW DOSE

ASPIRIN REGIMEN

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

OUR PHARMACISTS RECOMMEND

Aspirin 81 mg

Chewable

PAIN RELIEVER (NSAID)

actual size

ORANGE FLAVOR

VALUE PACK!

3 BOTTLES INSIDE

3 X 36 TABLETS (81mg EACH) = 108 TABLETS

108 TOTAL TABLETS

Topcare Aspirin
aspirin tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-467
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 81 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
FD&C YELLOW NO. 6
SACCHARIN SODIUM
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 8mm
Flavor ORANGE Imprint Code L467
Contains
Packaging
# Item Code Package Description
1 NDC:36800-467-68 1 BOTTLE in 1 CARTON
1 36 TABLET, CHEWABLE in 1 BOTTLE
2 NDC:36800-467-08 3 BOTTLE in 1 CARTON
2 36 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 08/24/1992
Labeler - Topco Associates LLC (006935977)
Topco Associates LLC

Frequently asked questions

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