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Midol Extended Relief (naproxen sodium 220 mg fd&c blue no. 2 0.21 mg hypromelloses 150.00 mg magnesium stearate 256.40 mg cellulose, microcrystalline 551.25 mg povidone k25 4.40 mg talc 220.40 mg titanium dioxide 1387.00 mg) Dailymed

  1. Human OTC
  2. Archived
    • May Be Discontinued
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  3. Bayer HealthCare LLC.

Generic: naproxen sodium

Midol Extended Relief tablet - (naproxen sodium 220 mg fd&c blue no. 2 0.21 mg hypromelloses 150.00 mg magnesium stearate 256.40 mg cellulose, microcrystalline 551.25 mg povidone k25 4.40 mg talc 220.40 mg titanium dioxide 1387.00 mg) image

IMPRINT: MIDOL     SHAPE: oval
    COLOR: blue

  1. FDA Adverse Reactions

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Drug Facts

Active Ingredient (in Each Caplet)


Naproxen sodium 220 mg (naproxen 200 mg) (NSAID) nonsteroidal anti-inflammatory drug

Purposes


Pain reliever/fever reducer

Uses


temporarily relieves minor aches and pains due to:
  • menstrual cramps
  • muscle aches
  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • the common cold
  • temporarily reduces fever

Warnings


Allergy alert


Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • bulers

If an allergic reaction occurs, stop use and seek medical help right away.

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 SECTION


Do not use
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

OTC - ASK DOCTOR SECTION


Ask a doctor before use if
  • the 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 are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have asthma

OTC - ASK DOCTOR/PHARMACIST SECTION


Ask a doctor or pharmacist before use if you are
  • under a doctor's care for any serious condition
  • taking any other drug

OTC - WHEN USING SECTION


When using this product
  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed.

OTC - STOP USE SECTION


Stop use and ask a doctor if
  • 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
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • you have difficulty swallowing
  • it feels like the pill is stuck in your throat
  • redness or swelling is present in the painful area
  • any new symptoms appear

OTC - PREGNANCY OR BREAST FEEDING SECTION


If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium 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 SECTION


Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • do not take more than directed
  • the smallest effective dose should be used
  • drink a full glass of water with each dose
under 12 years
  • ask a doctor
adults and children 12 years and older
  • take 1 caplet every 8 to 12 hours while symptoms last. For the first dose you may take 2 caplets within the first hour. Do not exceed 2 caplets in any 8- to 12-hour period. Do not exceed 3 caplets in a 24-hour period.

Other Information

  • each caplet contains: sodium 20 mg
  • store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).

Inactive Ingredients


FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

Questions Or Comments?


1-800-331-4536

(Mon-Fri 9-5 EST) or www.midol.com

Principal Display Panel - 220 Mg Carton


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Bayer HealthCare

Midol ®

Extended Relief for up to 12 HOURS

Naproxen Sodium Tablets, 220 mg Pain Reliever/Fever Reducer (NSAID)

Temporarily Relieves Minor Cramps-Backache-Headache

20 CAPLETS* *Capsule-Shaped Tablets

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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