SPL v2
SPL
SPL Set ID 1b2e6566-cb7c-7a7d-e063-6394a90af97c
Route
ORAL
Published
Effective Date 2024-06-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Sodium Lauryl Sulfate Croscarmellose Sodium Methacrylic Acid - Ethyl Acrylate Copolymer (1:2) Starch, Corn Cellulose, Microcrystalline Fd&c Yellow No. 6 Talc Titanium Dioxide Polyethylene Glycol, Unspecified Hypromellose, Unspecified Stearic Acid D&c Yellow No. 10

Identifiers & Packaging

Pill Appearance
Imprint: PH023 Shape: round Color: yellow Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-01

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 may not provide fast relief of headache or other symptoms needing immediate relief.
  • ask your doctor about other uses for this product
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 alergic reaction which may include:

  • hives
  • asthma (wheezing)
  • facial sweling
  • 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 while symptoms persist. Do not to exceed 48 tablets in 24 hours or as directed by a physician
  • children under 12 years: consult a physician
Do Not Use

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

Other Information
  • Tamper Evident: Do not use if the safety seal under the cap is broken or missing
  • store at room temperature (15°-30°C)
  • avoid excess heat and moisture
Inactive Ingredients

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

Ask A Doctor Before Use If
  • the 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
  • allergic reaction occurs
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • any new symptoms occur
  • ringing in the ears or 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 accidental overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet)

Aspirin 81mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Questions? Adverse Drug Event Call:

(866) 562-2756

Package Label Principal Display Panel

PHARMAMED

NDC 84289-356-12

Manufactured in the U.S.A

Pain Reliever (NSAID) / Adult Low Dose

Aspirin

Aspirin 81mg

120 TABS

ENTERIC COATED

Aspirin Regimen

*Compare to the active ingredient in BAYER Low dose

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 may not provide fast relief of headache or other symptoms needing immediate relief.
  • ask your doctor about other uses for this product
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 alergic reaction which may include:

  • hives
  • asthma (wheezing)
  • facial sweling
  • 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 while symptoms persist. Do not to exceed 48 tablets in 24 hours or as directed by a physician
  • children under 12 years: consult a physician
Do Not Use (Do not use)

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

Other Information (Other information)
  • Tamper Evident: Do not use if the safety seal under the cap is broken or missing
  • store at room temperature (15°-30°C)
  • avoid excess heat and moisture
Inactive Ingredients (Inactive ingredients)

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

Ask A Doctor Before Use If (Ask a doctor before use if)
  • the 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
  • allergic reaction occurs
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • any new symptoms occur
  • ringing in the ears or loss of hearing occurs

These could be signs of a serious condition.

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 accidental overdose, get medical help or contact a Poison Control Center right away.

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

Aspirin 81mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Questions? Adverse Drug Event Call: (Questions? Adverse drug event call:)

(866) 562-2756

Package Label Principal Display Panel

PHARMAMED

NDC 84289-356-12

Manufactured in the U.S.A

Pain Reliever (NSAID) / Adult Low Dose

Aspirin

Aspirin 81mg

120 TABS

ENTERIC COATED

Aspirin Regimen

*Compare to the active ingredient in BAYER Low dose

Ask A Doctor Or Pharmacist Before Use If You Are Taking A Prescription Drug For: (Ask a doctor or pharmacist before use if you are taking a prescription drug for:)
  • gout
  • diabetes
  • arthritis

Advanced Ingredient Data


Raw Label Data

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