MEDIQUE PRODUCTS CHEWABLE LOW DOSE ASPIRIN- aspirin tablet, chewable

Medique Products Chewable Low Dose Aspirin by

Drug Labeling and Warnings

Medique Products Chewable Low Dose Aspirin by is a Otc medication manufactured, distributed, or labeled by Unifirst First Aid Corporation, Prestige Packaging, Medique Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Drug Facts

Active ingredient

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Purpose

Pain reliever

Uses

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor

Warnings

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 alcohol drinks every day while using this product

■ take more or for a longer time than directed

Do not use

Do not use

• if you are allergic to aspirin or to any other pain reliever/fever reducer
• this product 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

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

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

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 more than 10 days

■ ringing in the ears or loss of hearing occurs

■ redness or swelling is present

■ new symptoms occur

If pregnant or breast-feeding

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 specifically directed to do so by a doctor because if may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Directions

■ drink a full glass of water with each

Adults and children 12 years and over:

take 4 or 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

Other information

■ store at room temperature

■ tamper evident sealed packets

■ do not use any opened or torn packets

Inactive ingredients

Inactive ingredients

corn starch, dextrates, FD&C yellow # 6 aluminum lake, orange flavor, saccharin sodium

Questions or comments?

Questions or comments? 1-800-634-7680

Medique Chewable Low Dose Aspirin 81 mg

Medique®

Chewable Low Dose

Aspirin

81 mg

Pain reliever (NSAID*)

*nonsteroidal anti-inflammatory drug

THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.

**Talk to your doctor or other healthcare provider

before using this product for your heart.

Compare active ingredient to Bayer® Chewable Low Dose Aspirin

Registered Trademark Bayer Consumer

Tamper Evident Unit Dose Packets

24

Tablets

(24 x 1)

INGREDIENTS AND APPEARANCE

MEDIQUE PRODUCTS CHEWABLE LOW DOSE ASPIRIN 
aspirin tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-038
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
DEXTRATES (UNII: G263MI44RU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	7mm
Flavor	ORANGE	Imprint Code	AZ013
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-038-64	24 in 1 BOX	04/26/2024
1	NDC: 47682-038-46	1 in 1 PACKET; 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	04/26/2024

Labeler - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Prestige Packaging		080667761	pack(47682-038)

Establishment
Name	Address	ID/FEI	Business Operations
Medique Products		086911794	pack(47682-038)