TOPCARE 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:
Topco Associates LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever for the temporary relief of minor aches and pains
Authorization status:
OTC monograph not final
Authorization number:
36800-467-08, 36800-467-68

TOPCARE ASPIRIN- aspirin tablet, chewable

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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Topco Associates LLC. Aspirin 81 mg Drug Facts

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpos e

Pain reliever

Us es

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:

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach

bleeding. The chance is higher if you

Do not use

hives

facial swelling

asthma (wheezing)

shock

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

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

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

Stop use and ask a doctor if

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

Other information

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

diabetes

gout

arthritis

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

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

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

store at 20-25°C (68-77°F)

TOPCARE ASPIRIN

aspirin tablet, chewable

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:36 8 0 0 -46 7

Route of Administration

ORAL

Topco Associates LLC

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)

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

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

Product Characteristics

Color

ORANGE

S core

no sco re

S hap e

ROUND

S iz e

8 mm

Flavor

ORANGE

Imprint Code

L46 7

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:36 8 0 0 -46 7-6 8

1 in 1 CARTON

0 8 /24/19 9 2

1

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

2

NDC:36 8 0 0 -46 7-0 8

3 in 1 CARTON

0 1/17/20 18

2

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

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt343

0 8 /24/19 9 2

Labeler -

T opco Associates LLC (006935977)

Revised: 4/2019

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