Naproxen Sodium Tablet [Vitamex Usa] -

NAPROXEN SODIUM TABLET [VITAMEX USA]
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NDC	69469-169-24
Set ID	97522a07-47ca-42aa-94e0-e28c279a08cf
Category	HUMAN OTC DRUG LABEL
Packager	Vitamex USA
Generic Name
Product Class
Product Number
Application Number	ANDA079096

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Active ingredient (in each caplet)

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug
Purposes

Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
  - headache
  - muscular aches
  - minor pain of arthritis
  - toothache
  - backache
  - the common cold
  - menstrual cramps
- 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
- have 3 or more alcoholic drinks every day while using this product
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- 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 have problems or serious side effects from taking pain relievers or fever reducers
- you have asthma
- you are taking a diuretic
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
  - have bloody or black stools
  - vomit blood
  - 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
- redness or swelling is present in the painful area
- any new symptoms appear
- you have difficulty swallowing
- it feels like the pill is stuck in your throat
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 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 20 mg
- store at 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat above 40°C (104°F).
- read all warnings and directions before use. Keep carton.
Inactive ingredients

croscarmellose sodium, FD&C blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, titanium dioxide
Questions or comments?

Call 1-800-653-0160
Principal Display Panel
REDUCES FEVER

RELIEVES PAIN OF:
- ARTHRITIS
- HEADACHE
- BACKACHE
- MENSTRUAL CRAMPS
- TOOTHACHE
- COMMON COLD
SEE WARNINGS INFORMATION

FOR THE RELIEF OF MUSCULAR ACHES

TABLETS

DO NOT USE IF INNER SEAL UNDER BOTTLE CAP PRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by

VitaMex, Inc.

Orlando, FL 32837

USA

www.vitamexusa.com
Product Label

Arthrofin Naproxen Sodium 220 mg

INGREDIENTS AND APPEARANCE

NAPROXEN SODIUM
naproxen sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69469-169
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	12mm
Flavor		Imprint Code	13
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69469-169-24	1 in 1 BOX	03/31/2016	12/30/2021
1		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA079096	03/31/2016	12/30/2021

Labeler - Vitamex USA (054256676)

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Medic

NAPROXEN SODIUM TABLET [VITAMEX USA]

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

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