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Aspirin Enteric Coated by Chain Drug Consortium

Dosage form: tablet
Ingredients: ASPIRIN 325mg
Labeler: Chain Drug Consortium
NDC Code: 68016-045

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.

Drug Facts

Active ingredient

Aspirin 325 mg (NSAID*)
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

relief of minor aches, pains or as recommended by your doctor. 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 ■ asthma (wheezing) ■ shock

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

Do Not Use

if you are allergic to aspirinor other pain relievers/fever reducers

Ask Doctor before use if

stomach bleeding warning applies to you you have history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic

Ask Doctor/Pharmacist before use if you are

taking a prescription drug for anticoagulation (thinning the blood) diabetes gout arthritis

Stop Use and ask a doctor if

an allergic reaction occurs. Seek medical help right away you experience any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, have stomach pain that does not get better new symptoms occur redness or swelling is present ringing in the ears or loss of hearing occurs pain gets worse or lasts for more than 10 days

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.

Keep Out of Reach of Children

In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Directions

■ drink a full glass of water with each dose ■ adults and children 12 years and over: take 1 or 2 tablets every 4 hours not to exceed 12 tablets in 24 hours unless directed by a doctor ■ children under 12 years: consult a doctor

Inactive Ingredients

acetylated monoglycerides, corn starch, croscarmellose sodium, D&C Yellow 10, FD&C Yellow #6, hypromellose, hypromellose phthalate, microcrystalline cellulose, mineral oil, polyethylene glycol 400, polysorbate 80, titanium dioxide

Package/Label Principal Display Panel
ASPIRIN  ENTERIC COATED
regular strength aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-045
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
DIACETYLATED MONOGLYCERIDES 
STARCH, CORN 
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
HYPROMELLOSES 
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST) 
CELLULOSE, MICROCRYSTALLINE 
LIGHT MINERAL OIL 
POLYETHYLENE GLYCOL 400 
POLYSORBATE 80 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeNone
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-045-65125 TABLET in 1 BOX
2NDC:68016-045-05500 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34310/27/2014
Labeler - Chain Drug Consortium (101668460)
Registrant - Chain Drug Consortium (101668460)
Establishment
NameAddressID/FEIOperations
A&Z Pharmaceutical, Inc.926820705LABEL(68016-045), MANUFACTURE(68016-045), PACK(68016-045), RELABEL(68016-045), REPACK(68016-045)

 
Chain Drug Consortium

← See all Aspirin Enteric Coated brands

Medically reviewed on Oct 29, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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