Your browser does not support JavaScript! ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MCKESSON (SUNMARK)]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

ENTERIC COATED ASPIRIN REGULAR STRENGTH (aspirin) tablet, coated
[Mckesson (Sunmark)]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

  • temporarily relieves minor aches and pains due to:
  • headache
  • menstrual pain
  • minor arthritis pain
  • muscle pain
  • toothache
  • colds
  • or as recommended by a doctor

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 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 have ever had an allergic reaction to aspirin or any other pain reliever/ fever reducer

Ask a doctor before use if

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

Ask a doctor or pharmacist before use if you are

taking a prescription drug for diabetes, gout, or arthritis

Stop use and ask a doctor if

  • 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

  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • any new symptoms appear
  • ringing in the ears or a loss of hearing occurs

These could be signs of a serious condition.

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 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: 1-800-222-1222

Directions

  • adults and children 12 years of age and over: take 1 to 2 tablets every 4 hours, while symptoms persist. Drink a full glass of water with each dose.
  • do not take more than 12 tablets in 24 hours unless directed by a doctor
  • children under 12 years of age: ask a doctor

Other information

  • store at controlled room temperature 15o- 30o C (59o- 86o F)

Inactive ingredients

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

Questions or comments?

call toll free 1-877-753-3935

PRINCIPAL DISPLAY PANEL

COMPARE TO ECOTRIN® ACTIVE INGREDIENT

SEE NEW WARNINGS INFORMATION

enteric coated aspirin

Regular strength

Pain reliever (NSAID)*

PROTECTS AGAINST ASPIRIN STOMACH UPSET

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

†This product is not manufactured or distributed by Glaxosmithkline, owner of the registered trademark Ecotrin®

Another quality product distributed by McKesson

one post street, San francisco, CA 94104

Money back gurantee

Please visit us at www.sunmarkbrand.com

Product label

 Sunmark enteric coated aspirin 325 mg

Aspirin 325 mg orange

ENTERIC COATED ASPIRIN  REGULAR STRENGTH
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49348-937
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
POLYSORBATE 80 
DIMETHICONE 
SODIUM HYDROXIDE 
SODIUM LAURYL SULFATE 
TALC 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code T
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-937-821 in 1 BOX
1125 in 1 BOTTLE, PLASTIC
2NDC:49348-937-14500 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34309/15/2010
Labeler - Mckesson (Sunmark) (177667227)

Revised: 9/2012
 
Mckesson (Sunmark)

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services