Naproxen sodium by Camber Consumer Care / InvaTech Pharma Solutions LLC NAPROXEN SODIUM tablet

Naproxen sodium by

Drug Labeling and Warnings

Naproxen sodium by is a Otc medication manufactured, distributed, or labeled by Camber Consumer Care, InvaTech Pharma Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

(in each tablet)
Naproxen sodium 220mg
(naproxen 200mg) (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                               ■ 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.

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

■ 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 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 of swelling is present in the painful area
■ any new symptoms appear
You may report side effects to FDA at 1-800-FDA-1088

PREGNANCY/BREASTFEEDING

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 andchildren 12 yearsand over: ■ 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-hr period
• Children under 12 years: ■ ask a doctor

OTHER INFORMATION

■ each tablet contains: sodium 20mg
■ store at 20 to 250C (68 to 770F). Avoid high
humidity and excessive heat above 400C (1040F).

INACTIVE INGREDIENTS

FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, sodium starch glycolate, starch, talc, titanium dioxide

QUESTIONS OR COMMENTS

888-588-1418 (MON - FRI 9 AM to 5 PM EST)

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

PRINCIPAL DISPLAY PANEL

Naproxen Sodium 50s container label

Naproxen Sodium 50s container carton label

Naproxen Sodium 100s container label

Naproxen Sodium 100s container carton label

Naproxen Sodium 500s container label

INGREDIENTS AND APPEARANCE

NAPROXEN SODIUM 
naproxen sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69230-313
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
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE (LIGHT BLUE)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	ET10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69230-313-50	1 in 1 CARTON	12/11/2019
1		50 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 69230-313-01	1 in 1 CARTON	12/11/2019
2		100 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 69230-313-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA207612	12/11/2019

Labeler - Camber Consumer Care (079539968)

Establishment
Name	Address	ID/FEI	Business Operations
InvaTech Pharma Solutions LLC		078602180	MANUFACTURE(69230-313)