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NDC 69230-0329-50 Naproxen sodium 220 mg/1 Details

Naproxen sodium 220 mg/1

Naproxen sodium is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Camber Consumer Care Inc. The primary component is NAPROXEN SODIUM.

Product Information

NDC	69230-0329
Product ID	69230-329_ee21e0f7-9f32-6c63-e053-2a95a90ac996
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Naproxen sodium
Proprietary Name Suffix	n/a
Non-Proprietary Name	Naproxen sodium
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	220
Active Ingredient Units	mg/1
Substance Name	NAPROXEN SODIUM
Labeler Name	Camber Consumer Care Inc
Pharmaceutical Class	Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA211065
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69230-0329-50 (69230032950)

Pricing Information	N/A
NDC Package Code	69230-329-50
Billing NDC	69230032950
Package	1 BOTTLE in 1 CARTON (69230-329-50) / 50 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date	2022-10-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d1008e19-ff0d-4ed2-909d-bae5a82a1234 Details

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

naproxensodium-round-100s-cont-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

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)
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA211065	10/28/2022

Labeler - Camber Consumer Care Inc (079539968)

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

Revised: 11/2022

Document Id: ee21e0f7-9f32-6c63-e053-2a95a90ac996

Set id: d1008e19-ff0d-4ed2-909d-bae5a82a1234

Version: 1

Effective Time: 20221123