FDA Label for Maximum Strength Backache Relief

Other

Drug Facts

Active Ingredient (In Each Caplet)

Magnesium salicylate tetrahydrate 580 mg (NSAID)

Nonsteroidal Anti-Inflammatory Drug

Purpose

pain reliever/fever reducer

Use

for the temporary relief of minor backache pain

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 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

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

Otc - Ask Doctor

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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are:

taking a prescription drug for

• gout
• diabetes
• arthritis

Otc - 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
  • 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.

  
  

Otc - Pregnancy Or Breast Feeding

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.

Otc - 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.

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.

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

Questions?

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

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

Principal Display Panel - 580 mg Caplet Packet Carton - backache 01