Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 9764367f-c26d-33ba-e053-2a95a90ab768
Route
ORAL
Published
Effective Date 2019-11-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
D&c Yellow No. 10 Hypromellose, Unspecified Stearic Acid Talc Food Yellow 3 Free Acid Croscarmellose Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A Cellulose, Microcrystalline Starch, Corn Titanium Dioxide Sodium Lauryl Sulfate Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: PH;023 Shape: round Color: yellow Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-10-02

Description

Aspirin 81mg (NSAID) † † nonsteroidal anti-inflammatory drug

Purpose

Pain reliever


Medication Information

Purpose

Pain reliever

Description

Aspirin 81mg (NSAID) † † nonsteroidal anti-inflammatory drug

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 headache or other symptoms needing immediate relief.
  • ask your doctor about other uses for this product
Section 51945-4

AMERICA'S PHARMACY SOURCE

COMPARE TO ACTIVE

INGREDIENT IN

BAYER ® LOW DOSE

LOW STRENGTH ASPIRIN

Aspirin

Enteric Coated Tablets

Pain Reliever (NSAID)

NDC# 72615-0064-1

120 TABLETS - 81mg Each

www.AmericasPharmacySource.com

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
  • asthma (wheezing)
  • shock

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
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 or as directed by a doctor
    children under 12 years ask a doctor

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 this product or any of its ingredients
Other Information
  • store at room temperature (15 0-30 0C)
  • avoid excess heat and moisture
Inactive Ingredients

croscarmellose sodium, D&C yellow# 10, FD&C yellow #6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide

Questions Or Comments?

(866) 562-2756 (Mon- Fri 8 AM to 4 PM EST)

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
Stop Use and Ask A Doctor If

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 •an allergic reaction occurs. Seek medical help right away.

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms occur
  • 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 (1-800-222-1222).

Active Ingredient (in Each Tablet)

Aspirin 81mg (NSAID)

nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug for:

  • gout
  • diabetes
  • arthritis

Structured Label Content

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 headache or other symptoms needing immediate relief.
  • ask your doctor about other uses for this product
Section 51945-4 (51945-4)

AMERICA'S PHARMACY SOURCE

COMPARE TO ACTIVE

INGREDIENT IN

BAYER ® LOW DOSE

LOW STRENGTH ASPIRIN

Aspirin

Enteric Coated Tablets

Pain Reliever (NSAID)

NDC# 72615-0064-1

120 TABLETS - 81mg Each

www.AmericasPharmacySource.com

Purpose

Pain reliever

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
  • asthma (wheezing)
  • shock

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
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 or as directed by a doctor
    children under 12 years ask a doctor

Do Not Use (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 this product or any of its ingredients
Other Information (Other information)
  • store at room temperature (15 0-30 0C)
  • avoid excess heat and moisture
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, D&C yellow# 10, FD&C yellow #6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

(866) 562-2756 (Mon- Fri 8 AM to 4 PM EST)

Ask A Doctor Before Use If (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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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 •an allergic reaction occurs. Seek medical help right away.

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms occur
  • ringing in the ears or loss of hearing occurs.
If Pregnant Or Breast Feeding, (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. (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).

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Aspirin 81mg (NSAID)

nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking a prescription drug for:

  • gout
  • diabetes
  • arthritis

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)