Pain Reliever

Pain Reliever
SPL v5
SPL
SPL Set ID 9da5b2ee-5ade-4a8d-93bd-693e035f62ae
Route
ORAL
Published
Effective Date 2021-11-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg)
Inactive Ingredients
Starch, Corn Croscarmellose Sodium D&c Yellow No. 10 Fd&c Yellow No. 6 Hypromelloses Methacrylic Acid Methacrylic Acid - Ethyl Acrylate Copolymer (1:2) Microcrystalline Cellulose Mineral Oil Polysorbate 80 Dimethicone Sodium Hydroxide Sodium Lauryl Sulfate Talc Titanium Dioxide Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: T Shape: round Color: orange Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-23

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

temporarily relieves minor aches and pains due to: • headache • minor arthritis pain • toothache • menstrual pain • colds • or as recommended by a doctor

Pouch

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 • shock • facial swelling • asthma (wheezing)

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

• adults and children 12 years of age and over: take 1 to 2 tablets every 4 hours, while symptoms persist. Drink a full glass of water with each dose.

• do not take more than 12 tablets in 24 hours unless directed by a doctor

• children under 12 years of age: ask a doctor

Do Not Use

if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

Drug Facts

Distributed By:

Cabinet Health P.B.C.

Other Information

• store between 20–25°C (68–77°F)

Inactive Ingredients

Corn starch, croscarmellose sodium, D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Questions Or Comments?

1-888-333-9792

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 • fever gets worse or lasts for more than 3 days • have stomach pain that does not get better • pain gets worse or lasts more than 10 days • redness or swelling is present • any new symptoms appear • ringing in the ears or a loss of hearing occurs. These could be signs of a serious condition.

Ask A Doctor Before Use If You

• 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

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.

Keep Out of Reach of Children.

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

Active Ingredient (in Each Tablet)

Aspirin 325 mg (NSAID)**



**nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are

if you are taking a prescription drug for diabetes, gout, or arthritis


Structured Label Content

Uses

temporarily relieves minor aches and pains due to: • headache • minor arthritis pain • toothache • menstrual pain • colds • or as recommended by a doctor

Pouch

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 • shock • facial swelling • asthma (wheezing)

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

• adults and children 12 years of age and over: take 1 to 2 tablets every 4 hours, while symptoms persist. Drink a full glass of water with each dose.

• do not take more than 12 tablets in 24 hours unless directed by a doctor

• children under 12 years of age: ask a doctor

Do Not Use (Do not use)

if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

Drug Facts

Distributed By: (Distributed by:)

Cabinet Health P.B.C.

Other Information (Other information)

• store between 20–25°C (68–77°F)

Inactive Ingredients (Inactive ingredients)

Corn starch, croscarmellose sodium, D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Questions Or Comments? (Questions or comments?)

1-888-333-9792

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 • fever gets worse or lasts for more than 3 days • have stomach pain that does not get better • pain gets worse or lasts more than 10 days • redness or swelling is present • any new symptoms appear • ringing in the ears or a loss of hearing occurs. These could be signs of a serious condition.

Ask A Doctor Before Use If You (Ask a doctor before use if you)

• 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

If Pregnant Or Breast Feeding, (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.

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 (1-800-222-1222).

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

Aspirin 325 mg (NSAID)**



**nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

if you are taking a prescription drug for diabetes, gout, or arthritis


Advanced Ingredient Data


Raw Label Data

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