LOW DOSE ASPIRIN 81 MG SAFETY COATED- aspirin tablet, delayed release 
Family Dollar (FAMILY WELLNESS)

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.

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Drug Facts

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 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.
  • ask your doctor about other uses for safety coated 81 mg 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:

  • hives
  • facial swelling
  • shock
  • asthma (wheezing)

Stomach bleeding warning: This product contains an NSAID, which may cause 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 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
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • ringing in the ears or loss of hearing occurs

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. 

Directions

  • drink a full glass of water with each dose
  • adults and children 12 years of age 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 of age: do not use

Other information

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

Inactive ingredients

anhydrous lactose**, black iron oxide**, brown iron oxide**, croscarmellose sodium**, D&C yellow #10, FD&C yellow #6**, hypromellose**, methacrylic acid copolymer, microcrystalline cellulose, mineral oil**, polysorbate 80**, potassium hydroxide**, pregelatinized starch**, propylene glycol**, purified water**, shellac**, silicon dioxide, simethicone**, sodium bicarbonate**, sodium hydroxide**, sodium lauryl sulfate**, stearic acid**, talc, titanium dioxide, triethyl citrate, yellow iron oxide**

**contains one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient of BAYER® Low Dose Aspirin†

Safety Coated

Low Dose Aspirin 81 mg

Pain Reliever (NSAID)

≠Aspirin Regimen

Tablets

†This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Low Dose Aspirin.

≠Aspirin is not appropriate for everyone, so be sure you talk to your doctor before you begin an aspirin regimen.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

VISIT FAMILYDOLLAR.COM

DISTRIBUTED BY:

FAMILY DOLLAR SERVICES, INC.,

10401 MONROE RD

MATTHEWS, NC 28105 USA

Product Label

Aspirin 81 mg

Family Wellness Low Dose Aspirin Tablets

LOW DOSE ASPIRIN 81 MG  SAFETY COATED
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-227
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
BROWN IRON OXIDE (UNII: 1N032N7MFO)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
STARCH, CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize7mm
FlavorImprint Code E;T81;1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-227-121 in 1 BOX07/31/201412/30/2021
1120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:55319-227-031 in 1 BOX07/31/201412/30/2021
2300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34307/31/201412/30/2021
Labeler - Family Dollar (FAMILY WELLNESS) (024472631)

Revised: 12/2019
 
Family Dollar (FAMILY WELLNESS)