backprin

backprin
SPL v2
SPL
SPL Set ID c8d1cffc-9483-4462-9f92-c0c2fbfc2b7c
Route
oral
Published
Effective Date 2023-08-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (580 mg)
Inactive Ingredients
polyethylene glycol, unspecified stearic acid cellulose, microcrystalline magnesium stearate polydextrose titanium dioxide hypromellose, unspecified triacetin

Identifiers & Packaging

Pill Appearance
Imprint: 44;338 Shape: capsule Color: white Size: 17 mm Score: 1
Marketing Status
otc monograph drug active Since 2023-01-09

Description

Active ingredient (in each caplet) Magnesium Salicylate Tetrahydrate (NSAID*) 580 mg (equivalent to 467.2 mg of anhydrous magnesium salicylate) *nonsteroidal anti-inflammatory drug


Medication Information

Warnings and Precautions

Warnings

Reye's syndrome:

Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's Syndrome, a rare but serious illness reported to be associated with salicylates.

Allergy alert:.

Magnesium salicylate 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

Active Ingredient

Active ingredient (in each caplet)

Magnesium Salicylate Tetrahydrate (NSAID*) 580 mg

(equivalent to 467.2 mg of anhydrous magnesium salicylate)

*nonsteroidal anti-inflammatory drug

Indications and Usage

Uses

Temporarily relieves minor back pain

Dosage and Administration

Directions

Do not take more than directed.

Adults and children 12 years of age and over:

■ take 2 caplets with a full glass of water every 6 hours while symptoms persist

■ do not take more than 8 caplets in 24 hours unless directed by a doctor

Children under 12 years: ask a doctor

Description

Active ingredient (in each caplet) Magnesium Salicylate Tetrahydrate (NSAID*) 580 mg (equivalent to 467.2 mg of anhydrous magnesium salicylate) *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. 1-800-222-1222

Section 50566-9

Stop use and ask a doctor if

■ an allergic reaction occurs, seek medical help right away

■ fever worsens or lasts more than 3 days

■ pain worsens or lasts more than 10 days

■ you experience any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or stomach pain that does not get better

■ ringing in the ears or loss of hearing occurs

■ new symptoms occur

■ redness or swelling is present

These could be signs of a serious condition.

Section 50568-5

Ask a doctor or pharmacist before use if you take any drug for diabetes, gout or arthritis

Section 50569-3

Ask a doctor before use if

■ stomach bleeding warning applies to you

■ you have a history of stomach problems, such as heartburn

■ you have asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease

■ you are taking a diuretic

Section 50570-1

Do not use if you are allergic to salicylates (including aspirin) or any other pain reliever/fever reducer

Section 51727-6

Inactive ingredients

hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, stearic acid, titanium dioxide, triacetin

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use magnesium salicylate 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.

Section 55105-1

Purpose

Pain reliever

Section 60561-8

Other information

■ caplets enclosed in a sealed packet

■ do not use if packet is torn, cut or open

■ store at 59° to 86°F (15°-30°C)

■ avoid excessive heat and humidity


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Reye's syndrome:

Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's Syndrome, a rare but serious illness reported to be associated with salicylates.

Allergy alert:.

Magnesium salicylate 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

Active Ingredient (55106-9)

Active ingredient (in each caplet)

Magnesium Salicylate Tetrahydrate (NSAID*) 580 mg

(equivalent to 467.2 mg of anhydrous magnesium salicylate)

*nonsteroidal anti-inflammatory drug

Indications and Usage (34067-9)

Uses

Temporarily relieves minor back pain

Dosage and Administration (34068-7)

Directions

Do not take more than directed.

Adults and children 12 years of age and over:

■ take 2 caplets with a full glass of water every 6 hours while symptoms persist

■ do not take more than 8 caplets in 24 hours unless directed by a doctor

Children under 12 years: ask a doctor

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. 1-800-222-1222

Section 50566-9 (50566-9)

Stop use and ask a doctor if

■ an allergic reaction occurs, seek medical help right away

■ fever worsens or lasts more than 3 days

■ pain worsens or lasts more than 10 days

■ you experience any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or stomach pain that does not get better

■ ringing in the ears or loss of hearing occurs

■ new symptoms occur

■ redness or swelling is present

These could be signs of a serious condition.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you take any drug for diabetes, gout or arthritis

Section 50569-3 (50569-3)

Ask a doctor before use if

■ stomach bleeding warning applies to you

■ you have a history of stomach problems, such as heartburn

■ you have asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease

■ you are taking a diuretic

Section 50570-1 (50570-1)

Do not use if you are allergic to salicylates (including aspirin) or any other pain reliever/fever reducer

Section 51727-6 (51727-6)

Inactive ingredients

hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, stearic acid, titanium dioxide, triacetin

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use magnesium salicylate 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.

Section 55105-1 (55105-1)

Purpose

Pain reliever

Section 60561-8 (60561-8)

Other information

■ caplets enclosed in a sealed packet

■ do not use if packet is torn, cut or open

■ store at 59° to 86°F (15°-30°C)

■ avoid excessive heat and humidity


Advanced Ingredient Data


Raw Label Data

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