Medique Back Pain Relief

Medique Back Pain Relief
SPL v5
SPL
SPL Set ID e5563a0a-776a-83d4-e053-2a95a90a9500
Route
ORAL
Published
Effective Date 2022-08-26
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 2022-09-26

Description

Drug Facts


Medication Information

Warnings and Precautions

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:

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 alcohol drinks every day while using this product

■ take more or for a longer time than directed

Indications and Usage

Uses

For the temporary releif of minor backache pain

Dosage and Administration

Directions

■ drink a full glass of water with each dose

Adults and children: (12 years and over)

Take 2 caplets every 6 hours, not to exceed 8 caplets in 24 hours.

Children under 12 years:

Do not use unless directed by a doctor

Description

Drug Facts

Section 42229-5

Drug Facts

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.

Section 50566-9

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 ■ have stomach pain that does not get better

■ if ringing in the ears or loss of hearing occurs

■ new symptoms occur

■ pain gets worse or lasts more than 10 days

■ fever gets worse or lasts more than 3 days

■ 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 are taking a prescription drug for

■ gout

■ diabetes

■ 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 high blood pressure, heart disease, liver cirrhosis, or kidney disease

■ you have asthma

■ 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

Medique®

Back Pain Relief

Pain Reliever/ Anti-Inflammatory

Pull to Open

Magnesium Salicylate Tetrahydrate (NSAID) 580 mg

80 Caplets (40 x 2)

Tamper Evident Unit Dose Packets

Section 53413-1

Questions or comments? 1-800-634-7680

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use. I t is especially important not to use magnesium salicylate at 20 weeks or later in pregnancy unless specifically 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 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

Section 60561-8

Other information

■ each caplet contains: magnesium 40 mg

■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

■ tamper evident sealed packets

■ do not use any opened or torn packets


Structured Label Content

Indications and Usage (34067-9)

Uses

For the temporary releif of minor backache pain

Dosage and Administration (34068-7)

Directions

■ drink a full glass of water with each dose

Adults and children: (12 years and over)

Take 2 caplets every 6 hours, not to exceed 8 caplets in 24 hours.

Children under 12 years:

Do not use unless directed by a doctor

Warnings and Precautions (34071-1)

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:

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 alcohol drinks every day while using this product

■ take more or for a longer time than directed

Section 42229-5 (42229-5)

Drug Facts

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.

Section 50566-9 (50566-9)

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 ■ have stomach pain that does not get better

■ if ringing in the ears or loss of hearing occurs

■ new symptoms occur

■ pain gets worse or lasts more than 10 days

■ fever gets worse or lasts more than 3 days

■ 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 are taking a prescription drug for

■ gout

■ diabetes

■ 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 high blood pressure, heart disease, liver cirrhosis, or kidney disease

■ you have asthma

■ 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)

Medique®

Back Pain Relief

Pain Reliever/ Anti-Inflammatory

Pull to Open

Magnesium Salicylate Tetrahydrate (NSAID) 580 mg

80 Caplets (40 x 2)

Tamper Evident Unit Dose Packets

Section 53413-1 (53413-1)

Questions or comments? 1-800-634-7680

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use. I t is especially important not to use magnesium salicylate at 20 weeks or later in pregnancy unless specifically 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 55106-9 (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

Section 60561-8 (60561-8)

Other information

■ each caplet contains: magnesium 40 mg

■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

■ tamper evident sealed packets

■ do not use any opened or torn packets


Advanced Ingredient Data


Raw Label Data

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