OTC Medication Information: Low Dose Aspirin

LOW DOSE ASPIRIN- aspirin tablet, coated
Strategic Sourcing Services LLC

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 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. 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 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 aspirin or any other pain reliever/fever reducer.
  • if you have ever had an allergic reaction to his product or any of its ingredients

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

  • gout
  • diabetes
  • 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 stool
    • have stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • fever get worse or lasts more than 3 days
  • redness or swelling is present
  • ringing in the ears or loss of hearing occurs
  • new symptoms occur

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 at during the last 3 month 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 (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: consult a doctor

Other information

  • store between 15-30ºC (59-86ºF)

Inactive ingredients

croscarmellose sodium, D&C yellow #10, lactose monohydrate, methacrylic acid, microcrystalline cellulose 102, polacrilin potassium, polyethylene glycol 6000, polyvinyl alcohol, purified talc, silicon dioxide, sodium lauryl sulfate, soybean, titanium dioxide, triethyl citrate

Questions or comments?

Call 1-833-358-6431 Monday to Friday 9:00am to 7:00pm EST

Principal Display Panel

COMPARE TO BAYER® LOW DOSE ASPIRIN ACTIVE INGREDIENT†

LOW DOSE

Aspirin 81 mg

PAIN RELIEVER (NSAID)

Aspirin regimen±

Enteric coated±±

Safety coated±±

TABLETS

†This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Bayer® Low Dose Aspirin.

≠Talk to your doctor or other healthcare provider before using this product for your heart. Aspirin is not right for everyone.

≠≠Coating helps protect against stomach upset

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: McKesson Corp.,

via Strategic Sourcing Services LLC. Memphis, TN 38141

www.fosterand thrive.com

Product Label

Aspirin 81 mg (NSAID)* *nonsteroidal anti-inflammatory drug
(click image for full-size original)

FOSTER & THRIVE Low Dose Aspirin

LOW DOSE ASPIRIN
aspirin tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-1150
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 81 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
METHACRYLIC ACID
SILICON DIOXIDE
POLACRILIN POTASSIUM
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
POLYETHYLENE GLYCOL 6000
SOYBEAN
POLYVINYL ALCOHOL, UNSPECIFIED
Product Characteristics
Color yellow Score no score
Shape ROUND Size 6mm
Flavor Imprint Code P
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70677-1150-2 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
1 180 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the BOX (70677-1150-2)
2 NDC:70677-1150-3 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
2 300 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the BOX (70677-1150-3)
3 NDC:70677-1150-1 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
3 120 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the BOX (70677-1150-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 04/01/2023
Labeler — Strategic Sourcing Services LLC (116956644)

Revised: 05/2023 Strategic Sourcing Services LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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