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← See all Regular Strength Enteric coated aspirin brands

Regular Strength Enteric coated aspirin

Dosage form: tablet, coated
Ingredients: ASPIRIN 325mg
Labeler: Bryant Ranch Prepack
NDC Code: 71335-0513

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.

Active ingredient (in each tablet)

Aspirin 325 mg(NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses
  • for the temporary relief of minor aches and pains
  • ask your doctor about other uses for aspirin

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:hivesfacial swellingasthma (wheezing)shockStomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:are age 60 or olderhave had stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have 3 or more alcoholic drinks every day while using this producttake more or for a longer time than directedDo not use if you are allergic to aspirin or any other pain reliever/fever reducer.Ask a doctor before use ifthe stomach bleeding warning applies to youyou are taking a diureticyou have a history of stomach problems, such as heartburnyou have: -high blood pressure -heart disease -liver cirrhosis  -kidney disease -asthmaAsk a doctor or pharmacist before use if you aretaking any other drug containing an NSAID (prescription or nonprescription)taking a blood thinning (anticoagulant) or steroid drug taking a prescription drug for diabetes, gout or arthritisStop use and ask a doctor ifyou 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 betteran allergic reaction occurs. Seek medical help right awaypain gets worse or lasts more than 10 daysredness or swelling is present fever gets worse or lasts more than 3 daysany new symptoms occur ringing in the ears or loss of hearing occursIf 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 definitely 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 overdose, get medical help or contact a Poison Control Center right away.

Directions
  • drink a full glass of water with each dose
  • swallow whole, do not chew or crush
  • do not exceed recommended dose
  • adults and children 12 years and older: take 1-2 tablets every 4 hours, as needed, not more than 12 tablets in 24 hours, or as directed by a doctor
  • children under 12 years: ask a doctor

Other information
  • store at room temperature 15⁰C - 30⁰C (59⁰F - 86⁰F)
  • for institutional use only

Inactive ingredients

cellulose, D and C yellow #10, FD and C yellow #6, hypromellose, iron oxide, PEG, polydextrose, polyvinyl acetate phthalate, propylene glycol, shellac wax, silica, simethicone, sodium alginate, sodium bicarbonate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate. May also contain: acetylated monoglycerides, croscarmellose sodium, hypromellose phthalate, methacrylic acid, mineral oil, polysorbate 80, sodium lauryl sulfate.

HOW SUPPLIED

Product: 71335-0513

NDC: 71335-0513-3 100 TABLET, COATED in a BOTTLE

NDC: 71335-0513-6 45 TABLET, COATED in a BOTTLE

NDC: 71335-0513-4 90 TABLET, COATED in a BOTTLE

NDC: 71335-0513-1 30 TABLET, COATED in a BOTTLE

NDC: 71335-0513-7 120 TABLET, COATED in a BOTTLE

NDC: 71335-0513-2 60 TABLET, COATED in a BOTTLE

NDC: 71335-0513-5 20 TABLET, COATED in a BOTTLE

Aspirin E.C 325mg Tablet
REGULAR STRENGTH ENTERIC COATED ASPIRIN  
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0513(NDC:57896-921)
Route of AdministrationORALDEA ScheduleCIV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE 
STARCH, CORN 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
HYPROMELLOSE, UNSPECIFIED 
POLYVINYL ACETATE PHTHALATE 
MICROCRYSTALLINE CELLULOSE 
POLYDEXTROSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
PROPYLENE GLYCOL 
SHELLAC 
SILICON DIOXIDE 
STEARIC ACID 
SODIUM BICARBONATE 
SODIUM ALGINATE 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
TRIETHYL CITRATE 
DIMETHICONE 
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize9mm
FlavorImprint Code44;227
Contains    
Packaging
#Item CodePackage Description
1NDC:71335-0513-3100 TABLET, COATED in 1 BOTTLE
2NDC:71335-0513-645 TABLET, COATED in 1 BOTTLE
3NDC:71335-0513-490 TABLET, COATED in 1 BOTTLE
4NDC:71335-0513-130 TABLET, COATED in 1 BOTTLE
5NDC:71335-0513-7120 TABLET, COATED in 1 BOTTLE
6NDC:71335-0513-260 TABLET, COATED in 1 BOTTLE
7NDC:71335-0513-520 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34307/01/2000
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIOperations
Bryant Ranch Prepack171714327REPACK(71335-0513), RELABEL(71335-0513)

Revised: 12/2017
 
Bryant Ranch Prepack

← See all Regular Strength Enteric coated aspirin brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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