Naproxen Sodium by Granules India Limited NAPROXEN SODIUM tablet

Drug Details [pdf]

ACTIVE INGREDIENT

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug
PURPOSE

Pain reliever/fever reducer
INDICATIONS AND USAGE
- 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 DOCTOR
- 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 DOCTOR/PHARMACIST
- under a doctor’s care for any serious condition
- taking any other drug
WHEN USING
- 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
- 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
- you develop heartburn
- redness or swelling is present in the painful area
- any new symptoms appear
PREGNANCY 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 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
Children under 12 years	ask a doctor

Information for Patients

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)
do not use if foil seal on bottle opening is missing or broken.

INACTIVE INGREDIENT

FD&C blue#2 aluminum lake, hypromellose 2910, maize starch, microcrystalline cellulose, polyethylene glycol, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide
QUESTIONS

1-877-770-3183 Mon – Fri 9:00 AM to 4:00 PM EST

M.L. 37/RR/AP/2003/F/R

MADE IN INDIA

Manufactured By:

Granules India Limited

2nd Floor 3rd Block, My Home hub

Madhapur, Hyderabad – 500 081, India
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

$C:\Users\Administrator\Desktop\spl sci\spl2\nap-sod capsule-shaped-tablets.jpg$

$C:\Users\Administrator\Desktop\spl sci\spl2\nap-sod tablets.jpg$

INGREDIENTS AND APPEARANCE

NAPROXEN SODIUM
naproxen sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62207-750
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)

Product Characteristics
Color	blue (Light Blue)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	I1
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 62207-750-41	24 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2011
2	NDC: 62207-750-42	50 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2011
3	NDC: 62207-750-43	43 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2011
4	NDC: 62207-750-44	150 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2011
5	NDC: 62207-750-45	200 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2011
6	NDC: 62207-750-47	500 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2011
7	NDC: 62207-750-49	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2011
8	NDC: 62207-750-51	10 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2011
9	NDC: 62207-750-52	300 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2011
10	NDC: 62207-750-53	400 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA091353	09/30/2011

NAPROXEN SODIUM
naproxen sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62207-753
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)

Product Characteristics
Color	blue (Light Blue)	Score	no score
Shape	OVAL (Capsule-Shaped)	Size	12mm
Flavor		Imprint Code	220
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 62207-753-41	24 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2011
2	NDC: 62207-753-42	50 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2011
3	NDC: 62207-753-43	43 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2011
4	NDC: 62207-753-44	150 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2011
5	NDC: 62207-753-45	200 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2011
6	NDC: 62207-753-47	500 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2011
7	NDC: 62207-753-49	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2011
8	NDC: 62207-753-51	10 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2011
9	NDC: 62207-753-52	300 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2011
10	NDC: 62207-753-53	400 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA091353	09/30/2011

Labeler - Granules India Limited (915000087)

Name	Address	ID/FEI	Business Operations
Establishment
Granules India Limited		918609236	manufacture(62207-750, 62207-753) , analysis(62207-750, 62207-753) , pack(62207-750, 62207-753)

Naproxen Sodium by Granules India Limited NAPROXEN SODIUM tablet

Naproxen Sodium by

Drug Labeling and Warnings

Drug Details [pdf]

Information for Patients