Label: NAPROXEN SODIUM tablet
- NDC Code(s): 51316-762-70
- Packager: CVS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 18, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each caplet)
- Purposes
- Uses
- Allergy alert:
-
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 product take more or for a longer time than directed
- Heart attack and stroke warning:
- 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 had 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
- When Using this Product
-
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 - If pregnant or breast-feeding,
- 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 doseAdults and children 12 years and older
take 1 caplet every 8 to 12 hours while symptoms last
for the first dose you may take 2 caplets within the first hour
do not exceed 2 caplets in any 8- to12-hour period
do not exceed 3 caplets in a 24-hour periodChildren under 12 years
ask a doctor
- Other information
- Inactive Ingredients
- Questions or Comments?
- Principal display panel
-
INGREDIENTS AND APPEARANCE
NAPROXEN SODIUM
naproxen sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51316-762 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 SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE K30 (UNII: U725QWY32X) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) Product Characteristics Color blue (Light Blue) Score no score Shape OVAL ((Caplet -Shaped)) Size 12mm Flavor Imprint Code 220 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51316-762-70 270 in 1 BOTTLE; Type 0: Not a Combination Product 05/25/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091353 05/25/2024 Labeler - CVS (062312574)