Label: NAPROXEN SODIUM tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 50090-4704-0 - Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 69230-313
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 9, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
-
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
-
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
- WHEN USING THIS PRODUCT
-
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
- KEEP OUT OF REACH OF CHILDREN
-
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 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
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS
- Naproxen sodium
-
INGREDIENTS AND APPEARANCE
NAPROXEN SODIUM
naproxen sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-4704(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) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (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:50090-4704-0 30 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 - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-4704) , REPACK(50090-4704)