LOW DOSE ASPIRIN ENTERIC SAFETY COATED- aspirin tablet, delayed release
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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LEADER 328R

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

Each Tablet contains Aspirin 81 mg (NSAID)

*Nonsteroidal anti-inflamatory drug

Anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscamellose sodium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, iron oxide ochre, methacrylic acid, ethyl acrylate copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, triethyl citrate

PAIN RELEIVER

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 more or for a longer time than directed.

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.

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

image description

LOW DOSE ASPIRIN ENTERIC SAFETY COATED
aspirin tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0203
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
METHACRYLIC ACID (UNII: 1CS02G8656)
ETHYL ACETATE (UNII: 76845O8NMZ)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	white (ENTERIC COATED PEACH)	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	emobssed;upper;heart;lower;plain
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0203-1	120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/06/2017	12/27/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part343	08/11/2010	12/27/2019

Labeler - CARDINAL HEALTH (097537435)

Registrant - TIME CAP LABORATORIES, INC (037052099)

Name	Address	ID/FEI	Business Operations
Establishment
TIME CAP LABORATORIES, INC		037052099	manufacture(70000-0203)

Revised: 12/2019

Document Id: 98cf3386-e531-6fd3-e053-2a95a90a3de7

Set id: 34b224d4-5162-4019-9604-da67a36e6e44

Version: 3

Effective Time: 20191203

CARDINAL HEALTH