gc 921

gc 921
SPL v7
SPL
SPL Set ID bda805ab-7f37-405d-a144-4e06ad9a29a1
Route
oral
Published
Effective Date 2024-04-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
aspirin (325 mg)
Inactive Ingredients
ferrosoferric oxide starch, corn d&c yellow no. 10 fd&c yellow no. 6 hypromellose, unspecified polyvinyl acetate phthalate microcrystalline cellulose polydextrose polyethylene glycol, unspecified propylene glycol shellac silicon dioxide stearic acid sodium bicarbonate sodium alginate talc titanium dioxide triacetin triethyl citrate dimethicone

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

Purpose

Pain reliever

How Supplied

Aspirin 325 mg(NSAID)* *nonsteroidal anti-inflammatory drug. NDC: 71335-0513-1: 30 Tablets in a BOTTLE NDC: 71335-0513-2: 60 Tablets in a BOTTLE NDC: 71335-0513-3: 100 Tablets in a BOTTLE NDC: 71335-0513-4: 90 Tablets in a BOTTLE NDC: 71335-0513-5: 20 Tablets in a BOTTLE NDC: 71335-0513-6: 45 Tablets in a BOTTLE NDC: 71335-0513-7: 120 Tablets in a BOTTLE NDC: 71335-0513-8: 7 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Description

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


Medication Information

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
  • if you ever had an allergic reaction to this product or any of its ingredients

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 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 at 20 weeks or later in

pregnancy unless definitely directed to do so by a doctor because it may

cause problems in the unborn child or complications during delivery.

Active Ingredient

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
Purpose

Pain reliever

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: do not use unless directed by a doctor
Other Information
  • store at 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F)
Inactive Ingredients

black iron oxide, cellulose, corn starch, D&C yellow #10 lake, FD&C yellow #6 lake, hypromellose, polydextrose,

polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, silicon dioxide, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate.

How Supplied

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

NDC: 71335-0513-1: 30 Tablets in a BOTTLE

NDC: 71335-0513-2: 60 Tablets in a BOTTLE

NDC: 71335-0513-3: 100 Tablets in a BOTTLE

NDC: 71335-0513-4: 90 Tablets in a BOTTLE

NDC: 71335-0513-5: 20 Tablets in a BOTTLE

NDC: 71335-0513-6: 45 Tablets in a BOTTLE

NDC: 71335-0513-7: 120 Tablets in a BOTTLE

NDC: 71335-0513-8: 7 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Description

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

Section 50565-1

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

Section 51945-4

Aspirin E.C 325 mg Tablet

Questions Or Comments?

1-800-540-3765


Structured Label Content

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
  • if you ever had an allergic reaction to this product or any of its ingredients

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 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 at 20 weeks or later in

pregnancy unless definitely directed to do so by a doctor because it may

cause problems in the unborn child or complications during delivery.

Active Ingredient (Active ingredient (in each tablet))

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
Purpose

Pain reliever

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: do not use unless directed by a doctor
Other Information (Other information)
  • store at 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F)
Inactive Ingredients (Inactive ingredients)

black iron oxide, cellulose, corn starch, D&C yellow #10 lake, FD&C yellow #6 lake, hypromellose, polydextrose,

polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, silicon dioxide, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate.

How Supplied (HOW SUPPLIED)

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

NDC: 71335-0513-1: 30 Tablets in a BOTTLE

NDC: 71335-0513-2: 60 Tablets in a BOTTLE

NDC: 71335-0513-3: 100 Tablets in a BOTTLE

NDC: 71335-0513-4: 90 Tablets in a BOTTLE

NDC: 71335-0513-5: 20 Tablets in a BOTTLE

NDC: 71335-0513-6: 45 Tablets in a BOTTLE

NDC: 71335-0513-7: 120 Tablets in a BOTTLE

NDC: 71335-0513-8: 7 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

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.

Section 51945-4 (51945-4)

Aspirin E.C 325 mg Tablet

Questions Or Comments? (Questions or comments?)

1-800-540-3765


Advanced Ingredient Data


Raw Label Data

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