NAPROXEN SODIUM by ADVANCED FIRST AID, INC. / ULTRA SEAL CORPORATION / MARKSANS PHARMA LIMITED NAPROXEN SODIUM tablet

NAPROXEN SODIUM by

Drug Labeling and Warnings

NAPROXEN SODIUM by is a Otc medication manufactured, distributed, or labeled by ADVANCED FIRST AID, INC., ULTRA SEAL CORPORATION, MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT IN EACH TABLET-

Naproxen 200 mg

(naproxen 200 mg)(NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSE

pain reliever/fever reducer

INDICATIONS & USAGE

Uses: temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headaches toothache temporarily reduces fever

WARNINGS

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

Stomach Bleeding Warning: This product contains 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 you are taking a diuretic you have problems or serious side effects from taking pain relievers 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 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

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 for 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

PREGNANCY OR BREAST FEEDING

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 specifically 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

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions: do not use more than directed the smallest effective dose should be used drink a full glass of water with each dose

Adults and children 12 years of age and older:  Take 1 tablet every 8 - 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 a 24 hour period

Children under 12 years: ASK a doctor.

INACTIVE INGREDIENT

Inactive Ingredients: FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, propylene glycol, povidone, talc, titanium dioxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NAPROXEN SODIUM 
naproxen sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67060-000
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)	NAPROXEN	200

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	blue	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	141
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67060-000-68	50 in 1 CARTON	04/09/2015
1		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090545	04/09/2015

Labeler - ADVANCED FIRST AID, INC. (114477180)

Registrant - ADVANCED FIRST AID, INC. (114477180)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA SEAL CORPORATION		085752004	pack(67060-000)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	manufacture(67060-000)