Enteric Coated Aspirin by CARDINAL HEALTH / TIME CAP LABORATORIES, INC LEADER 331R

Enteric Coated Aspirin by

Drug Labeling and Warnings

Enteric Coated 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]

ENTERIC COATED ASPIRIN REGULAR STRENGTH- 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 331R

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 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor
• children under 12 years: consult a doctor

corn starch, croscarmellose sodium,D-C yellow #10 aluminum lake, FD-C yellow#6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose,mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Use for the temporary relief of minor aches and pains due to:

headache, colds, muscle pain, menstrual pain, toothache, minor pain of arthritis or as directed by your doctor

Pain Reliever

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, asthmaaa9wheezing)

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, take more or for a longer time than directed.

In each Tablet Asprin 325 mg (NSAID*) *non-steroidal anti-inflammatory drug

ENTERIC COATED ASPIRIN  REGULAR STRENGTH
aspirin tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0237
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg  in 325

Inactive Ingredients
Ingredient Name	Strength
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
HYPROMELLOSES (UNII: 3NXW29V3WO)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	T
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0237-1	125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/21/2017	12/27/2019
2	NDC: 70000-0237-2	300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/21/2017	12/27/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	02/21/2017	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(70000-0237)

Revised: 12/2019

Document Id: 98cfdbf4-7807-ac2b-e053-2995a90adb96

34390-5

Set id: 4f31fc1d-2a1f-4fd5-84e3-17858765d97c

Version: 2

Effective Time: 20191203

 

CARDINAL HEALTH