SPL v1
SPL
SPL Set ID 2e17664f-a83f-48d1-8b2b-37f41eea65b6
Route
ORAL
Published
Effective Date 2024-07-01
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 2024-07-01

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

Purpose

Purpose Pain reliever


Medication Information

Purpose

Purpose

Pain reliever

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

Stop Use

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
  • 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.

Warnings

Warnings

Questions

Questions or comments? (888) 602-0288

Ask Doctor

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
Do Not Use

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

Allergy Alert:

Magnesium salicylate may cause a severe allergic reaction, which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
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.

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

Inactive Ingredient

Inactive ingredients

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

Indications & Usage

Uses

For the temporary relief of minor backache pain

Ask Doctor/pharmacist

Ask a doctor or pharmacist before use if you are taking a prescription drug for

  • gout
  • diabetes
  • arthritis
Dosage & Administration

Directions

  • drink a full glass of water with each dose
Children Under 12 Years:

Do not use unless directed by a doctor

Other Safety Information

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
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
Pregnancy Or Breast Feeding

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.

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

Adults and Children: (12 Years and Over)

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

Principal Display Panel – 50 Caplet Box Label

2550

BACK PAIN RELIEF

Magnesium Salicylate Tetrahydrate 580 mg (NSAID)

Pain Reliever / Anti-Inflammatory

Pull to Open

50 Caplets

2 Per Packet

The Provision

First Aid

Line™

BY WILDMAN


Structured Label Content

Purpose (PURPOSE)

Purpose

Pain reliever

Stop Use (STOP USE)

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
  • 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.

Warnings (WARNINGS)

Warnings

Questions (QUESTIONS)

Questions or comments? (888) 602-0288

Ask Doctor (ASK DOCTOR)

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
Do Not Use (DO NOT USE)

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

Allergy Alert: (Allergy alert:)

Magnesium salicylate may cause a severe allergic reaction, which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
Reye's Syndrome: (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.

Active Ingredient (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

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients

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

Indications & Usage (INDICATIONS & USAGE)

Uses

For the temporary relief of minor backache pain

Ask Doctor/pharmacist (ASK DOCTOR/PHARMACIST)

Ask a doctor or pharmacist before use if you are taking a prescription drug for

  • gout
  • diabetes
  • arthritis
Dosage & Administration (DOSAGE & ADMINISTRATION)

Directions

  • drink a full glass of water with each dose
Children Under 12 Years: (Children under 12 years:)

Do not use unless directed by a doctor

Other Safety Information (OTHER SAFETY INFORMATION)

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
Stomach Bleeding Warning: (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
Pregnancy Or Breast Feeding (PREGNANCY OR BREAST FEEDING)

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.

Keep Out of Reach of Children (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 (1-800-222-1222) right away.

Adults and Children: (12 Years and Over) (Adults and children: (12 years and over))

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

Principal Display Panel – 50 Caplet Box Label

2550

BACK PAIN RELIEF

Magnesium Salicylate Tetrahydrate 580 mg (NSAID)

Pain Reliever / Anti-Inflammatory

Pull to Open

50 Caplets

2 Per Packet

The Provision

First Aid

Line™

BY WILDMAN


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)