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aspirin

Time-Cap Labs, Inc

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENTS

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




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

Purpose

PURPOSE:  Pain reliever

Uses

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

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: 
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..

aspirin

aspirin

aspirin TABLET, CHEWABLE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49483-334
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
aspirin ASPIRIN 81 mg

Inactive Ingredients

Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
DEXTRATES
FD&C YELLOW NO. 6
cellulose, microcrystalline
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)
ORANGE
STARCH, CORN
SACCHARIN SODIUM DIHYDRATE
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
orange 8 mm UPPER;tcl334;LOWER;PLAIN ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49483-334-63 36 in 1 BOTTLE, PLASTIC
2 NDC:49483-334-00 100000 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2010-07-16


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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