LOW DOSE ASPIRIN- aspirin tablet, chewable

Low Dose Aspirin by

Drug Labeling and Warnings

Low Dose Aspirin by is a Otc medication manufactured, distributed, or labeled by CHAIN DRUG MARKETING ASSOCIATION INC, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each chewable 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 

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
• shock
• asthma (wheezing)

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

• take a blood thinning (anticoagulant) or steroid drug 
• are age 60 or older
• 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
• have had stomach ulcers or bleeding problems
  
• 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
• for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor 
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

• you have asthma
• stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you are taking a diuretic 
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

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:
  • vomit blood
    
  • have bloody or black stools
  • feel faint
    
  • 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 at 20 weeks or later in 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

• do not take more than directed
• drink a full glass of water with each dose
• chew or crush tablets completely before swallowing; do not swallow tablets whole
• adults and children 12 years and over: take 4 to 8 chewable tablets every 4 hours not to exceed 48 chewable 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• see end flap for expiration date and lot number

Inactive ingredients

corn starch, dextrates hydrated, FD&C yellow #6 aluminum lake, flavor, maltodextrin, sucralose

Questions or comments?

1-800-426-9391

Principal Display Panel

QC®
QUALITY
CHOICE

NDC: 63868-332-36

†Compare to the Active Ingredient in
Bayer® Chewable Low Dose Aspirin

Low Dose
Aspirin
81 mg Chewable Tablets
Pain Reliever (NSAID)

Chew or crush tablets completely
before swallowing.

36 Chewable Tablets

actual size

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®
Chewable Low Dose Aspirin.

50844        REV0122A21807

Distributed by CDMA, Inc.
43157 W Nine Mile
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362

SATISFACTION 
100%
QC®
GUARANTEED

Quality Choice 44-218A

INGREDIENTS AND APPEARANCE

LOW DOSE ASPIRIN 
aspirin tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-332
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	8mm
Flavor	ORANGE	Imprint Code	44;218
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-332-36	1 in 1 CARTON	07/02/2021
1		36 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	07/02/2021

Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	pack(63868-332)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	manufacture(63868-332)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	manufacture(63868-332)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	pack(63868-332)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		117025878	manufacture(63868-332)