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  5. Label Information: Aspirin Low Dose Chewable

FDA Label for Aspirin Low Dose Chewable

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. OTC - KEEP OUT OF REACH OF CHILDREN
    3. INACTIVE INGREDIENT
    4. OTC - PURPOSE
    5. INDICATIONS & USAGE
    6. DOSAGE & ADMINISTRATION
    7. WARNINGS
    8. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aspirin Low Dose Chewable Product Label

The following document was submitted to the FDA by the labeler of this product Time-cap Labs, Inc. 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.

Active Ingredients



Drug Facts
Active ingredient (in each tablet) Purpose
Aspirin 81 mg (NSAID*). . . . . . . . . . . . . . . . . . .Pain reliever
*nonsteroidal anti-inflammatory drug


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.  In case of overdose get medical help or contact a Poison Control Center right away.

Inactive Ingredient



Inactive ingredients: bht, dextrates, FD-C yellow #6 aluminum Lake, microcrystalline cellulose, modified corn starch, orange flavor, pregelatinized starch, sodium saccharin, stearic acid


Otc - Purpose



PURPOSE:  Pain reliever


Indications & Usage



Uses • temporarily relieves minor aches and pains
• for other uses, see your doctor, but do not use for more
than 10 days without consulting your doctor because
serious side effects may occur


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


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 serous Illinois. 

Allergy alert:  Aspirin may cause a severe allergic reaction, which may include: facial swelling, shock, hives, 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, tae more or for a longer time than directed..


Package Label.Principal Display Panel



334label - 334BOTTLE

334label - 334BOTTLE


* Please review the disclaimer below.