FDA Label for Doans Extra Strength

Other

Drug Facts

Active Ingredient (In Each Caplet)

Magnesium salicylate tetrahydrate 580 mg (NSAID)

nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

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 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

Otc - Do Not Use

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

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

Otc - Ask Doctor/Pharmacist

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

• gout
• diabetes
• arthritis

Stop Use And Ask A Doctor If

• you experience any of the following signs of stomach bleeding:
  • vomit blood
  • feel faint
  • have bloody or black stools
  • have stomach pain that does not get better
  • an allergic reaction occurs. Seek medical help right away.
  • new symptoms occur
  • redness or swelling is present
  • ringing in the ears or loss of hearing occurs
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days

  These could be signs of a serious condition.

  
  

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use magnesium salicylate during the last 3 months of 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: 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

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
• each caplet contains: magnesium 50 mg
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• see end flap for expiration date and lot number

Inactive Ingredients

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

Questions Or Comments?

1-800-790-6417

Principal Display Panel - 24 Caplet Bottle Box

NDC 55741-224-24

EXTRA STRENGTH

DOAN'S^®
MAGNESIUM SALICYLATE TETRAHYDRATE 580 mg each (NSAID)
PAIN RELIEVER

RELIEVES
BACKACHE
PAIN

24 CAPLETS

Principal Display Panel - 24 Caplet Bottle Box - doans 01