Label: PAIN AND FEVER RELIEF- naproxen sodium tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 72090-003-01 - Packager: Pioneer Life Sciences, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 18, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses:
-
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. -
Ask Doctor:
■ 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 DOCTOR/PHARMACIST:
-
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 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
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- Do not Use:
- When using this product
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PAIN AND FEVER RELIEF
naproxen sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72090-003 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN 220 mg Inactive Ingredients Ingredient Name Strength POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) TALC (UNII: 7SEV7J4R1U) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) MAGNESIUM STEARATE (UNII: 70097M6I30) WATER (UNII: 059QF0KO0R) Product Characteristics Color blue ((Light Blue)) Score no score Shape OVAL Size 12mm Flavor Imprint Code ET;9 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72090-003-01 300 in 1 BOTTLE; Type 0: Not a Combination Product 05/19/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207612 05/19/2021 Labeler - Pioneer Life Sciences, LLC (014092742)