Maximum Strength Backache Relief

Maximum Strength Backache Relief
SPL v2
SPL
SPL Set ID f8cbcd4e-cfad-4592-8774-52e681494c45
Route
ORAL
Published
Effective Date 2024-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (580 mg)
Inactive Ingredients
Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polydextrose Polyethylene Glycol, Unspecified Stearic Acid Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: 44;338 Shape: capsule Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-26

Description

Drug Facts

Purpose

pain reliever/fever reducer


Medication Information

Purpose

pain reliever/fever reducer

Description

Drug Facts

Use

for the temporary relief of minor backache pain

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
    • 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 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 53414-9

If pregnant or breastfeeding, 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.

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.
Do Not Use
  • if you are allergic to salicylates (including aspirin) or to any other pain reliever/fever reducer
  • for more than 10 days for pain unless directed by a doctor
Questions?

1-866-651-3660 Monday-Friday 8:00am-5:00pm EST

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.

Other Information
  • Each caplet contains: magnesium 40mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • tamper evident sealed packets
  • do not use if packet is opened or torn
Inactive Ingredient

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

Stomach Bleeding Warning

This product contains a nonsteroidal anti-inflammatory drug (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 a prescription or nonprescription NSAID (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 (in Each Caplet)

Magnesium salicylate tetrahydrate 580 mg (NSAID)

Nonsteroidal Anti-Inflammatory Drug
(equivalent to 467.2 mg of anhydrous magnesium salicylate)

Principal Display Panel 580 Mg Caplet Packet Carton

This product is not manufactured or distributed by

Dr Reddy's Laboratories, Inc

Owner of the registered trademark Doan's®.

Maximum Strength

Backache Relief

Product #1272

Pain Reliever/Fever Reducer

Active ingredient:

Magnesium Salicylate

  • Temporary relief from pain, fever, and inflammation
  • Soothes muscle aches and minor arthritis pain

These quality comfort tablets are formulated and packaged for use in the

workplace and meet ANSI Z308.1-2021 standards. They are sealed in

tamper-evident packets for safety and convenience.

80 Caplets • 2 Caplets Per Packet


Structured Label Content

Use

for the temporary relief of minor backache pain

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
    • 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 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 53414-9 (53414-9)

If pregnant or breastfeeding, 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.

Purpose

pain reliever/fever reducer

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.
Do Not Use (Do not use)
  • if you are allergic to salicylates (including aspirin) or to any other pain reliever/fever reducer
  • for more than 10 days for pain unless directed by a doctor
Questions?

1-866-651-3660 Monday-Friday 8:00am-5:00pm EST

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.

Other Information
  • Each caplet contains: magnesium 40mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • tamper evident sealed packets
  • do not use if packet is opened or torn
Inactive Ingredient (Inactive ingredient)

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

Stomach Bleeding Warning (Stomach bleeding warning)

This product contains a nonsteroidal anti-inflammatory drug (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 a prescription or nonprescription NSAID (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 (in Each Caplet) (Active ingredient (In Each Caplet))

Magnesium salicylate tetrahydrate 580 mg (NSAID)

Nonsteroidal Anti-Inflammatory Drug
(equivalent to 467.2 mg of anhydrous magnesium salicylate)

Principal Display Panel 580 Mg Caplet Packet Carton (PRINCIPAL DISPLAY PANEL - 580 mg Caplet Packet Carton)

This product is not manufactured or distributed by

Dr Reddy's Laboratories, Inc

Owner of the registered trademark Doan's®.

Maximum Strength

Backache Relief

Product #1272

Pain Reliever/Fever Reducer

Active ingredient:

Magnesium Salicylate

  • Temporary relief from pain, fever, and inflammation
  • Soothes muscle aches and minor arthritis pain

These quality comfort tablets are formulated and packaged for use in the

workplace and meet ANSI Z308.1-2021 standards. They are sealed in

tamper-evident packets for safety and convenience.

80 Caplets • 2 Caplets Per Packet


Advanced Ingredient Data


Raw Label Data

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