Greenfield Aspirin 81mg

Greenfield Aspirin 81mg
SPL v3
SPL
SPL Set ID 847fd2f8-2e32-4ef2-a793-b902045110f1
Route
ORAL
Published
Effective Date 2021-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Silicon Dioxide Starch, Corn Crospovidone D&c Yellow No. 10 Aluminum Lake Fd&c Yellow No. 6 Hypromellose, Unspecified Methacrylic Acid Microcrystalline Cellulose Stearic Acid Talc Titanium Dioxide Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: A Shape: round Color: yellow Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-19

Description

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

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

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

Use(s)

for the temporary relief of minor aches and pain 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.

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 unless directed by a doctor
  • children under 12 years: consult 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
  • save carton for full directions and warnings
  • store at room temperature
  • do not use if imprinted seal under safety cap is broken or missing

Active Ingredient(s)

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Inactive Ingredients

colloidal silicon dioxide, corn starch, crospovidone, D&C yellow #10 aluminum lake,

FD&C yellow #6 aluminum lake,hypromellose, methacrylic acid copolymer,

microcrystalline cellulose, stearic acid, talc, titanium dioxide, triethyl citrate

Pregnancy/breastfeeding

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 specifically

directed to do so  by a doctor because it may cause problems in the unborn child or

complications during delivery.

Principal Display Panel

Aspirin
Aspirin


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
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 stools
  • have stomach pain that does not get better
  • pain gets worse or lasts more than10 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs
  • You may report side effects to 1-888-952-0050
Keep Out of Reach of Children

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

Ask A Doctor Or Pharmacist Before Use If
  • taking a prescription drug for anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

Structured Label Content

Use(s)

for the temporary relief of minor aches and pain 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.

Purpose

Pain reliever/fever reducer

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 unless directed by a doctor
  • children under 12 years: consult 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)
  • save carton for full directions and warnings
  • store at room temperature
  • do not use if imprinted seal under safety cap is broken or missing

Active Ingredient(s) (Active ingredient(s))

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, corn starch, crospovidone, D&C yellow #10 aluminum lake,

FD&C yellow #6 aluminum lake,hypromellose, methacrylic acid copolymer,

microcrystalline cellulose, stearic acid, talc, titanium dioxide, triethyl citrate

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

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 specifically

directed to do so  by a doctor because it may cause problems in the unborn child or

complications during delivery.

Principal Display Panel

Aspirin
Aspirin


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 are taking a diuretic
  • you have asthma
Stop Use and Ask A Doctor If (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 stools
  • have stomach pain that does not get better
  • pain gets worse or lasts more than10 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs
  • You may report side effects to 1-888-952-0050
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.

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)
  • taking a prescription drug for anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

Advanced Ingredient Data


Raw Label Data

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