ldr 921

ldr 921
SPL v6
SPL
SPL Set ID 8aaa82c6-b46b-25c5-e053-2a95a90a3793
Route
oral
Published
Effective Date 2012-11-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
aspirin (325 mg)
Inactive Ingredients
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 stearic acid sodium bicarbonate sodium alginate talc titanium dioxide triacetin

Identifiers & Packaging

Pill Appearance
Imprint: 44;227 Shape: round Color: orange Size: 9 mm Score: 1
Marketing Status
otc monograph drug active Since 2019-04-01

Purpose

Pain reliever

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.

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. These may 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 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 or as recommended by your doctor

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 ask a doctor
Other Information
  • store at room temperature 15⁰C - 30⁰C (59⁰F - 86⁰F)
Inactive Ingredients

cellulose, D&C yellow #10 lake, FD&C yellow #6 lake, hypromellose, iron oxide, PEG, polydextrose, polyvinyl acetate phthalate, propylene glycol, silica, simethicone, sodium alginate, sodium bicarbonate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate, wax.

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 (1-800-222-1222) right away.

Package Label

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.

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. These may 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 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 or as recommended by your doctor

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 ask a doctor
Other Information (Other information)
  • store at room temperature 15⁰C - 30⁰C (59⁰F - 86⁰F)
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, silica, simethicone, sodium alginate, sodium bicarbonate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate, wax.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Package Label (package label)

Questions Or Comments? (Questions or comments?)

1-800-540-3765


Advanced Ingredient Data


Raw Label Data

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