FLANAX PAIN RELIEVER- naproxen sodium tablet

Flanax Pain Reliever by

Drug Labeling and Warnings

Flanax Pain Reliever by is a Otc medication manufactured, distributed, or labeled by Belmora LLC, Unifirst First Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts
Active Ingredient (in each tablet)

Naproxen sodium 220 mg (Naproxen 200 mg) (NSAID) 1

1 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
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

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.

DOSAGE & ADMINISTRATION

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

INGREDIENTS AND APPEARANCE

FLANAX PAIN RELIEVER
naproxen sodium tablet

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

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

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 27854-103-01	24 in 1 BOTTLE; Type 0: Not a Combination Product	12/16/2008	10/22/2019
2	NDC: 27854-103-04	10 in 1 BOTTLE; Type 0: Not a Combination Product	12/16/2008	10/22/2019
3	NDC: 27854-103-06	1 in 1 POUCH; Type 0: Not a Combination Product	12/16/2008
4	NDC: 27854-103-07	40 in 1 BOX	11/04/2019
4		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA079096	12/16/2008

Labeler - Belmora LLC (112753244)

Registrant - Unifirst First Aid Corporation (832947092)

Name	Address	ID/FEI	Business Operations
Establishment
Prestige Packaging		170837962	relabel(27854-103) , repack(27854-103)