DrugCite

ENTERIC ASPIRIN - aspirin tablet 
Cardinal Health

Enteric Aspirin 81 mg

Active ingredient

In each tablet: Aspirin 81 mg

Purpose

Pain Reliever

Keep Out of Reach of Children

Keep this and all drugs out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Uses

For the temporary relief of minor aches and pains or as recommended by your doctor.

Warnings

This package is intended for institutional use only. if pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer.

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).

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding.

Ask a doctor before use if you have asthma, ulcers, bleeding problems, stomach problems (such as heartburn, upset stomach or stomach pain) that persist or recur. Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation (blood thinning), gout, diabetes, or arthritis.

Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away if new symptoms occur, pain gets worse or lasts more than 10 days, redness or swelling is present ringing in the ears or loss of hearing occurs.

Directions

Consult a physician before the use of this product.

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.

Inactive ingredients

acetylated monoglycerides, anhydrous lactose, coiloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, hypromellose, hypromellose phthalate, iron oxide ochre, microcrystalline cellulose, mineral oil, polyethylene glycol (PEG)-400, polysorbate 80, titanium dioxide.

STORAGE: Store at 25 C (77 F) excursions permitted between 15-30 C (59-86 F)

SKY

Mfg. By: Time-Cap Labs, Inc. Farmingdale, NY 11735

Distributed By

McKesson Packaging Services

a business unit of McKesson Corporation

7101 Weddington Road

Concord, NC 28027

Validated with McKesson's PROmanager-Rx Automated storage & dispensing system for Package-Ready Oral solids

www.PROmanager-RX.com

Repackaged by Cardinal Health

Zanesville, OH 43701

Principal Display Panel

Enteric Aspirin

81 mg Tablets

10 Tablets

bag label

ENTERIC ASPIRIN 
enteric aspirin  tablet
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 55154-1476 (63739-272)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 81 mg
Inactive Ingredients
Ingredient Name Strength
GLYCERYL MONOOLEATE  
ANHYDROUS LACTOSE  
SILICON DIOXIDE  
CROSCARMELLOSE SODIUM  
D&C YELLOW NO. 10  
HYPROMELLOSES  
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)  
BROWN IRON OXIDE  
CELLULOSE, MICROCRYSTALLINE  
MINERAL OIL  
POLYETHYLENE GLYCOL 400  
POLYSORBATE 80  
TITANIUM DIOXIDE  
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 8
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 55154-1476-0 10 BLISTER PACK In 1 BAG contains a BLISTER PACK
1 1 TABLET In 1 BLISTER PACK This package is contained within the BAG (55154-1476-0)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 06/02/2011

Labeler - Cardinal Health (188557102)
Establishment
Name Address ID/FEI Operations
Cardinal Health 188557102 REPACK
Revised: 06/2011Cardinal Health