LOW DOSE ASPIRIN by CARDINAL HEALTH / TIME CAP LABORATORIES, INC 481R - LEADER

LOW DOSE ASPIRIN by

Drug Labeling and Warnings

LOW DOSE ASPIRIN by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH, TIME CAP LABORATORIES, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LOW DOSE ASPIRIN- aspirin tablet, coated 
CARDINAL HEALTH

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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481R - LEADER

Active ingredient (in each tablet) Purpose

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

*nonsteroidal anti-inflammatory drug

anhydrous lactose,

carnauba wax, colloidal silicon dioxide,

croscarmellose sodium, D&C yellow #10

aluminum lake, iron oxide ochre, methacrylic acid

and ethyl acrylate copolymer, microcrystalline

cellulose, polysorbate 80, simethicone, sodium

hydroxide, sodium lauryl sulfate, starch, talc,

titanium dioxide, triethyl citrate

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

Uses

_ temporarily relieves minor aches and pains

Because of its delayed action, this product will not

provide fast relief of headaches or other

symptoms needing immediate relief.

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 olde

r

Pain reliever

Keep out of reach of children. In case of

overdose, get medical help or contact a Poison

Control Center (1-800-222-1222) right away.

LOW DOSE ASPIRIN 
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0202
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0202-2	120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/02/2017	12/27/2019
2	NDC: 70000-0202-3	300 in 1 PACKAGE; Type 0: Not a Combination Product	01/18/2017	12/27/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/06/2017	12/27/2019

Labeler - CARDINAL HEALTH (097537435)

Registrant - TIME CAP LABORATORIES, INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES, INC		037052099	manufacture(70000-0202)

Revised: 12/2019

Document Id: 98cffa3c-4416-6a1d-e053-2995a90abcaf

34390-5

Set id: 76a21494-8c94-4da0-9608-fc70f787f070

Version: 6

Effective Time: 20191203