Drug Facts
Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Unifirst First Aid Corporation for the product Medique Products Chewable Low Dose Aspirin (NDC 47682-038). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
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
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
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
■ 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:
■ 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, 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. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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
■ store at room temperature
■ tamper evident sealed packets
■ do not use any opened or torn packets
Inactive ingredients
corn starch, dextrates, FD&C yellow # 6 aluminum lake, orange flavor, saccharin sodium
Questions or comments? 1-800-634-7680
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)
* Please review the disclaimer below.