FDA Label for Chewable Aspirin Adult Low Dose
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Chewable Aspirin Adult Low Dose Product Label
The following document was submitted to the FDA by the labeler of this product Medline Industries, Lp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient (in each tablet)
Aspirin 81 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Otc - Purpose
Purposes
Pain reliever
Indications & Usage
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 ■ shock ■ asthma (wheezing)
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
Otc - Do Not Use
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
■ if you have ever had an allergic reaction to this product or any of its
ingredients
Otc - 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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking a prescription
drug for ■ gout ■ diabetes ■ arthritis
Otc - Stop Use
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 stool ■ have stomach pain that does not get
better ■ pain gets worse or lasts more than 10 days ■ redness
or swelling is present ■ new symptoms occur ■ ringing in the ears
or loss of hearing occurs
Otc - 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.
Otc - 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 right away.
Dosage & Administration
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 Safety Information
Other information
■ store at room temperature
Inactive Ingredient
Inactive ingredients
corn starch, dextrates, FD&C yellow #6 aluminum lake, orange flavor,
saccharin sodium
Otc - Questions
Questions or comments?
Call toll free
1-800-MEDLINE (633-5463)
Monday-Friday 9AM-5PM CST
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