Aspirin 81mg

Aspirin 81mg
SPL v2
SPL
SPL Set ID 6a4c897d-c2a8-41b8-98b7-e7da8e2819ec
Route
ORAL
Published
Effective Date 2017-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Starch, Corn Fd&c Yellow No. 6 Magnesium Stearate Orange Silicon Dioxide Sucrose

Identifiers & Packaging

Pill Appearance
Imprint: AP;009 Shape: round Color: orange Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-04-01

Description

(in each tablet) Aspirin 81 mg (NSAID) * *nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever


Medication Information

Purpose

Pain Reliever

Description

(in each tablet) Aspirin 81 mg (NSAID) * *nonsteroidal anti-inflammatory drug

Use
  • temporarily relieves minor aches and pains
  • for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effect may occur.
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 signs of  Reye’s syndrome, a rare but serious illness.

Allergy Alert: Aspirin may cause a severe allergic reaction which may include

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

    Stomach Bleeding Warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child

  • has had stomach ulcers or bleeding problems
  • take a blood-thinning (anticoagulant) or steroid drug
  • takes other drugs containing prescription or nonprescription NSAIDs (ibuprofen, naproxen, others)
  • takes more or for a longer time than directed

    Do not use

  • if the child has ever had an allergic reaction to any other pain reliever / fever reducer
  • for at least 7 days after tonsillectomy or oral surgery

    Ask a doctor before use if

  • stomach bleeding warning applies to your child
  • child has a history of stomach problems, such as heartburn
  • child has not been drinking fluids
  • child has lost a lot of fluid due to vomiting and diarrhea
  • child has high blood pressure, heart disease, lever cirrhosis, or kidney disease
  • child is taking a diuretic
  • child has asthma

    Ask a doctor or pharmacist before use if the child is

  • taking a prescription drug for diabetes, gout or arthritis
  • taking any other drug
  • under a doctor’s care for any serious condition

    Stop use and ask a doctor if

  • child experiences any of the following signs of stomach bleeding:
  • feels faint
  • vomits blood
  • has bloody or black stools
  • has stomach pain that does not get better
  • pain gets worse or lasts more than 5 days
  • any new symptoms appear
  • redness or swelling is present in the painful area
  • ringing in the ears or a 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.

Directions
  • DRINK A FULL GLASS OF WATER WITH EACH DOSE

  • adults and children 12 years and older : take 4 to 8 tablets every 4 hours while symptoms last, but not more than 48 tablets in 24 hours.
  • Children under 12 years: ask a doctor
Active Ingredient

(in each tablet)

Aspirin 81 mg (NSAID) *

*nonsteroidal anti-inflammatory drug

Other Information
  • store at 15-30 °C (59-86 °F)
Inactive Ingredients

corn starch, FD&C Yellow #6 alum. lake, magnesium stearate, orange flavor, silicon dioxide, sugar

Questions Or Comments

Call 804-270-4498, 8.30am – 4.30 pm ET Monday-Friday

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

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Package Label.principal Display Panel

NDC: 54738-128-36 – 36 COUNT


Structured Label Content

Use
  • temporarily relieves minor aches and pains
  • for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effect may occur.
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 signs of  Reye’s syndrome, a rare but serious illness.

Allergy Alert: Aspirin may cause a severe allergic reaction which may include

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

    Stomach Bleeding Warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child

  • has had stomach ulcers or bleeding problems
  • take a blood-thinning (anticoagulant) or steroid drug
  • takes other drugs containing prescription or nonprescription NSAIDs (ibuprofen, naproxen, others)
  • takes more or for a longer time than directed

    Do not use

  • if the child has ever had an allergic reaction to any other pain reliever / fever reducer
  • for at least 7 days after tonsillectomy or oral surgery

    Ask a doctor before use if

  • stomach bleeding warning applies to your child
  • child has a history of stomach problems, such as heartburn
  • child has not been drinking fluids
  • child has lost a lot of fluid due to vomiting and diarrhea
  • child has high blood pressure, heart disease, lever cirrhosis, or kidney disease
  • child is taking a diuretic
  • child has asthma

    Ask a doctor or pharmacist before use if the child is

  • taking a prescription drug for diabetes, gout or arthritis
  • taking any other drug
  • under a doctor’s care for any serious condition

    Stop use and ask a doctor if

  • child experiences any of the following signs of stomach bleeding:
  • feels faint
  • vomits blood
  • has bloody or black stools
  • has stomach pain that does not get better
  • pain gets worse or lasts more than 5 days
  • any new symptoms appear
  • redness or swelling is present in the painful area
  • ringing in the ears or a 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.

Directions
  • DRINK A FULL GLASS OF WATER WITH EACH DOSE

  • adults and children 12 years and older : take 4 to 8 tablets every 4 hours while symptoms last, but not more than 48 tablets in 24 hours.
  • Children under 12 years: ask a doctor
Active Ingredient

(in each tablet)

Aspirin 81 mg (NSAID) *

*nonsteroidal anti-inflammatory drug

Other Information
  • store at 15-30 °C (59-86 °F)
Inactive Ingredients

corn starch, FD&C Yellow #6 alum. lake, magnesium stearate, orange flavor, silicon dioxide, sugar

Questions Or Comments (Questions or Comments)

Call 804-270-4498, 8.30am – 4.30 pm ET Monday-Friday

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

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.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC: 54738-128-36 – 36 COUNT


Advanced Ingredient Data


Raw Label Data

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