ASPIRIN LOW DOSE CHEWABLE- aspirin tablet, chewable

aspirin by

Drug Labeling and Warnings

aspirin by is a Otc medication manufactured, distributed, or labeled by Time-Cap Labs, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Active ingredient (in each tablet) Purpose

Aspirin 81 mg (NSAID*). . . . . . . . . . . . . . . . . . .Pain reliever

*nonsteroidal anti-inflammatory drug

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

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..

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASPIRIN  LOW DOSE CHEWABLE
aspirin tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49483-334
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
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DEXTRATES (UNII: G263MI44RU)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
ORANGE (UNII: 5EVU04N5QU)
STARCH, CORN (UNII: O8232NY3SJ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	UPPER;tcl334;LOWER;PLAIN
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49483-334-63	36 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/17/2018
2	NDC: 49483-334-00	100000 in 1 CARTON; Type 0: Not a Combination Product	12/17/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	07/16/2010

Labeler - Time-Cap Labs, Inc (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
Time-Cap Labs, Inc		037052099	manufacture(49483-334)