Gc 921

Gc 921
SPL v5
SPL
SPL Set ID a0705f4f-55cb-214a-e053-2995a90aa680
Route
ORAL
Published
Effective Date 2023-08-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg)
Inactive Ingredients
Stearic Acid Sodium Bicarbonate Sodium Alginate Talc Titanium Dioxide Triacetin Triethyl Citrate Dimethicone Ferrosoferric Oxide Starch, Corn D&c Yellow No. 10 Fd&c Yellow No. 6 Hypromelloses Polyvinyl Acetate Phthalate Cellulose, Microcrystalline Polydextrose Polyethylene Glycol, Unspecified Propylene Glycol Shellac Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;227 Shape: round Color: orange Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2000-07-01

Description

Aspirin 325 mg(NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever


Medication Information

Purpose

Pain reliever

Description

Aspirin 325 mg(NSAID)* *nonsteroidal anti-inflammatory drug

Uses
  • for the temporary relief of minor aches and pains
  • ask your doctor about other uses for aspirin
Section 50565-1

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

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

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer.

Ask a doctor before use if

  • the stomach bleeding warning applies to you
  • you are taking a diuretic
  • you have a history of stomach problems, such as heartburn
  • you have: -high blood pressure -heart disease -liver cirrhosis -kidney disease -asthma

Ask a doctor or pharmacist before use if you are

  • taking any other drug containing an NSAID (prescription or nonprescription)
  • taking a blood thinning (anticoagulant) or steroid drug
  • taking a prescription drug for diabetes, gout or arthritis

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
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days
  • 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.

Directions
  • drink a full glass of water with each dose
  • swallow whole, do not chew or crush

  • do not exceed recommended dose
  • adults and children 12 years and older: take 1-2 tablets every 4 hours, as needed, not more than 12 tablets in 24 hours, or as directed by a doctor
  • children under 12 years: ask a doctor
Package Label

Other Information
  • store at room temperature 15⁰C - 30⁰C (59⁰F - 86⁰F)
  • for institutional use only
Inactive Ingredients

cellulose, D&C yellow

#10 lake, FD&C yellow #6 lake, hypromellose, iron

oxide, PEG, polydextrose, polyvinyl acetate phthalate,

propylene glycol, shellac wax, silica, simethicone,

sodium alginate, sodium bicarbonate, starch, stearic

acid, talc, titanium dioxide, triacetin, triethyl citrate.

May also contain acetylated monoglycerides,

croscarmellose sodium, hypromellose phthalate,

methacrylic acid, mineral oil, polysorbate 80, sodium

lauryl sulfate.

Active Ingredient (in Each Tablet)

Aspirin 325 mg(NSAID)*



*nonsteroidal anti-inflammatory drug


Structured Label Content

Uses
  • for the temporary relief of minor aches and pains
  • ask your doctor about other uses for aspirin
Section 50565-1 (50565-1)

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

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

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer.

Ask a doctor before use if

  • the stomach bleeding warning applies to you
  • you are taking a diuretic
  • you have a history of stomach problems, such as heartburn
  • you have: -high blood pressure -heart disease -liver cirrhosis -kidney disease -asthma

Ask a doctor or pharmacist before use if you are

  • taking any other drug containing an NSAID (prescription or nonprescription)
  • taking a blood thinning (anticoagulant) or steroid drug
  • taking a prescription drug for diabetes, gout or arthritis

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
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days
  • 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.

Directions
  • drink a full glass of water with each dose
  • swallow whole, do not chew or crush

  • do not exceed recommended dose
  • adults and children 12 years and older: take 1-2 tablets every 4 hours, as needed, not more than 12 tablets in 24 hours, or as directed by a doctor
  • children under 12 years: ask a doctor
Package Label (package label)

Other Information (Other information)
  • store at room temperature 15⁰C - 30⁰C (59⁰F - 86⁰F)
  • for institutional use only
Inactive Ingredients (Inactive ingredients)

cellulose, D&C yellow

#10 lake, FD&C yellow #6 lake, hypromellose, iron

oxide, PEG, polydextrose, polyvinyl acetate phthalate,

propylene glycol, shellac wax, silica, simethicone,

sodium alginate, sodium bicarbonate, starch, stearic

acid, talc, titanium dioxide, triacetin, triethyl citrate.

May also contain acetylated monoglycerides,

croscarmellose sodium, hypromellose phthalate,

methacrylic acid, mineral oil, polysorbate 80, sodium

lauryl sulfate.

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

Aspirin 325 mg(NSAID)*



*nonsteroidal anti-inflammatory drug


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)