OTC Medication Information: Flanax Pain Reliever

FLANAX PAIN RELIEVER- naproxen sodium tablet
Belmora LLC

Drug Facts

Active Ingredient (in each tablet)

Naproxen Sodium USP 220 mg

Naproxen 200 mg (NSAID) 1


1

Purpose

Pain reliever/fever reducer

Uses

  • Temporarily relieves minor aches and pains due to:
    • minor pain of arthritis
    • muscular aches
    • backache
    • menstrual cramps
    • headache
    • 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
  • blisters

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

Heart attack and stroke warning:
NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

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, asthma or had a stroke
  • you are taking a diuretic
  • you have problems or serious side effects from taking pain reliever or fever reducers

Ask a doctor or pharmacist before use if you are

  • under a doctor’s care for any serious condition
  • taking any other drug

When using this product

  • take with food or milk if stomach upset occurs

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

  • you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
  • 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

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.

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

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

Other Information

  • each tablet contains: sodium 20 mg
  • store at 20-25°C (68-77°F).
  • Avoid high humidity and excessive heat above 40°C (104°F)
  • tamper evident sealed packets
  • do not use any open or torn packets

Inactive ingredients

croscarmellose sodium, FD&C Blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, titanium dioxide

Questions or comments ?

Call 1-888-779-2877 M-F, 9AM-5PM EST
Belmora LLC, 2011 Crystal Dr. Suite 400, Arlington, VA 22202

Belmora LLC FLANAX® Label

Belmora LLC Flanax®

Pain Reliever/Fever Reducer

NDC27854-103-07

Longer Lasting Pain Relief

For temporary Relief of Minor Aches & Pains

  • Headache
  • Backache
  • Arthritis
  • Fever
  • Menstrual Cramps
  • Toothache
  • Common Cold

20 Dual Packets

1 tablet Per Packet/ 40 Tablets

220 mg Tablets Naproxen Sodium USP (NSAID)

FlanaxPain
(click image for full-size original)
FLANAX PAIN RELIEVER
naproxen sodium tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:27854-103
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM 220 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
FD&C BLUE NO. 2
MAGNESIUM STEARATE
POVIDONE, UNSPECIFIED
CROSCARMELLOSE SODIUM (CROSCARMELLOSE)
POLYVINYL ALCOHOL, UNSPECIFIED
Product Characteristics
Color blue Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code I3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:27854-103-01 24 TABLET in 1 BOTTLE None
2 NDC:27854-103-04 10 TABLET in 1 BOTTLE None
3 NDC:27854-103-06 1 TABLET in 1 POUCH None
4 NDC:27854-103-07 40 PACKET in 1 BOX contains a PACKET
4 1 TABLET in 1 PACKET This package is contained within the BOX (27854-103-07)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079096 12/16/2008
Labeler — Belmora LLC (112753244)

Revised: 07/2021 Belmora LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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