Your browser does not support JavaScript! ASPIRIN 81 MG (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]
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RxNorm Names

ASPIRIN 81 MG (aspirin) tablet, coated
[DOLGENCORP, LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not 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 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

for the temporary relief of minor aches and pains or as recommended by your 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 change is higher is you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take more or for a longer time than directed
  • take other drugs containing prescription or nonprescription NSAIDs [aspiring, ibuprofen, naproxes, or others]

Do not use

if you are allergic 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 have asthma
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Stop use and ask a doctor if

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

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 unborn child or complications during deliver.

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 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
  • children under 12 years: do not use unless directed by a doctor

Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, silica, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

Call 1-888-309-9030

Principal Display Panel

DG
health

Compare to active ingredient in Bayer® Low Dose 81 mg Aspirin†

Aspirin 81 mg
Pain Reliever (NSAID)
Low Dose • Enteric Coated

Aspirin Regimen**

120 Tablets

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

50844    REV0612A60032

DISTRIBUTED BY DOLGENCORP, LLC
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072

Dollar General 44-600A

Dollar General 44-600A

ASPIRIN 81 MG 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55910-600
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE 
SILICON DIOXIDE 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
SODIUM BICARBONATE 
TITANIUM DIOXIDE 
TRIACETIN 
TRIETHYL CITRATE 
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize6mm
FlavorImprint Code L
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-600-321 in 1 CARTON
1120 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34302/12/2008
Labeler - DOLGENCORP, LLC (068331990)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(55910-600)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(55910-600)

Revised: 10/2013
 
DOLGENCORP, LLC

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