NAPROXEN SODIUM- naproxen sodium tablet, film coated

Naproxen sodium by

Drug Labeling and Warnings

Naproxen sodium by is a Otc medication manufactured, distributed, or labeled by Camber Consumer Care Inc, Annora Pharma Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

(in each tablet)
Naproxen sodium USP 220 mg (naproxen 200 mg) (NSAID)*                                                          
*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/ fever reducer
               

USE(S)

 temporarily relieves minor aches and pains due to:
    minor pain of arthritis
    muscular aches
    backache
    headache
    the common cold
    menstrual cramps 
    toothache
 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, kidney disease, asthma, or had a stroke
 you are taking a diuretic
 you have problems or serious side effects from taking pain relievers or fever reducers

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

 under a doctor's care for any serious condition
taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
 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

PREGNANCY/BREASTFEEDING

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in 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 a 24-hour period
• Children under 12 years:
  • ask a doctor

OTHER INFORMATION

 each tablet contains: sodium 21 mg
 Store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).

INACTIVE INGREDIENTS

corn starch, FD&C blue #2, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, talc and titanium dioxide.

QUESTIONS OR COMMENTS?

1-888-588-1418 (Mon - Fri 9AM - 5PM EST)
 
Do not use if bottle is open or if foil seal imprinted with "SEALED for YOUR PROTECTION" on bottle opening is missing or broken.
 

Mfg. Lic. No.: 24/MD/TS/2016/F/G

Distributed by:
Camber Consumer Care, Inc.
Piscataway, NJ 08854, USA.

PRINCIPAL DISPLAY PANEL

Naproxen Sodium Round Shape 100's container Label

 
Naproxen Sodium Round Shape 100's container Carton Label

INGREDIENTS AND APPEARANCE

NAPROXEN SODIUM  
naproxen sodium tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69230-329
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
STARCH, CORN (UNII: O8232NY3SJ)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Product Characteristics
Color	blue	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	H;N11
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69230-329-24	1 in 1 CARTON	10/28/2022
1		24 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 69230-329-50	1 in 1 CARTON	10/28/2022
2		50 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 69230-329-01	1 in 1 CARTON	10/28/2022
3		100 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 69230-329-02	1 in 1 CARTON	10/28/2022
4		200 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 69230-329-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	10/28/2022
6	NDC: 69230-329-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	10/28/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211065	10/28/2022

Labeler - Camber Consumer Care Inc (079539968)

Establishment
Name	Address	ID/FEI	Business Operations
Annora Pharma Private Limited		650980746	manufacture(69230-329)