FIRST AID DIRECT CHEWABLE ASPIRIN- aspirin tablet, chewable

First Aid Direct Chewable Aspirin by

Drug Labeling and Warnings

First Aid Direct Chewable Aspirin by is a Otc medication manufactured, distributed, or labeled by Cintas Corp, Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 or as recommended by your doctor
• ask your doctor about other uses for 81mg chewable aspirin

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 Allert: 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 are allergic to aspirin or any other pain reliever/fever reducer
• this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor 

ASK 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 DOCTOR/PHARMACIST

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 

• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you are taking a diuretic
• you have asthma

PREGNANCY 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 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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 room temperature
• Keep out of reach of children 

Inactive ingredients

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

Questions?

1-800-327-2704 M-F 8am - 5pm (CDT)

Principal Display Panel

LOW DOSE ASPIRIN

25 Chewable Tablets

1 Tablet per packet

Pain Reliever

Temporary relief of minor aches and pains or as recommended by your doctor

Compare active ingredient to Bayer® Chewable Aspirin

Manufactured for: fad first aid direct Mason, OH 45040

LOW DOSE ASPIRIN

PAIN RELIEVER (NSAID)

Each chewable tablet contains:

Aspirin 81mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Uses: For the temporary relief of minor aches and pains or as recommended by your doctor. Ask your doctor about other uses for 81mg chewable aspirin.

1 CHEWABLE TABLET PER PACKET

TAMPER EVIDENT.  DO NOT USE IF PACKET IS OPEN OR TORN. 

INGREDIENTS AND APPEARANCE

FIRST AID DIRECT CHEWABLE ASPIRIN 
aspirin tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42961-104
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)
DEXTRATES (UNII: G263MI44RU)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	8mm
Flavor	ORANGE	Imprint Code	AZ013
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42961-104-02	25 in 1 BOX	10/25/2021
1		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	10/25/2021

Labeler - Cintas Corp (056481716)

Establishment
Name	Address	ID/FEI	Business Operations
Allegiant Health		079501930	manufacture(42961-104)