FLANAX PAIN AND FEVER RELIEVER- naproxen sodium tablet

Flanax Pain and Fever Reliever by

Drug Labeling and Warnings

Flanax Pain and Fever Reliever by is a Otc medication manufactured, distributed, or labeled by Navajo Manufacturing Company Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Naproxen sodium 220 mg (Naproxen 200 mg) *(NSAID)

*nonsteroidal anti-inflammatory drug

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  also temporarily reduces fever.

Warnings

Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
 hives  asthma (wheezing)  skin reddening  facial swelling  shock  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 non-prescription 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

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

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 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

Stop use and ask a doctor if

 you experience any of the following signs of stomach bleeding:
you 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

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.

Directions

  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)

Inactive ingredients

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

Questions or comments?

Please Call 1-888-535-2629 M-F 9AM-5PM CST.

Package Labeling:

INGREDIENTS AND APPEARANCE

FLANAX PAIN AND FEVER RELIEVER 
naproxen sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-154(NDC:27854-103)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)	NAPROXEN SODIUM	220 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	blue	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor	HONEY	Imprint Code	I3
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67751-154-01	1 in 1 CARTON	09/20/2016
1		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079096	09/20/2016

Labeler - Navajo Manufacturing Company Inc. (091917799)

Establishment
Name	Address	ID/FEI	Business Operations
Navajo Manufacturing Company Inc.		136941411	relabel(67751-154) , repack(67751-154)