Label: NAPROXEN SODIUM capsule, liquid filled
- NDC Code(s): 0363-0102-15
- Packager: WALGREEN COMPANY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 29, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each capsule)
- Purposes
- Uses
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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
- Do not use
-
Ask a doctor before use if
- 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
- 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 capsule is stuck in your throat
- redness or swelling is present in the painful area
- any new symptoms appear
- PREGNANCY 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 dose
- if taken with food, this product may take longer to work
adults and children 12 years and older: - take 1 capsule every 8 hours to 12 hours while symptoms last
- for the first dose you may take 2 capsules within the first hour
- do not exceed 2 capsules in any 8-hour to 12-hour period
- do not exceed 3 capsules in a 24-hour period
children under 12 years: - ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
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SPL UNCLASSIFIED SECTION
DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS TORN OR MISSING
Walgreens Pharmacist Recommended
††This product is not manufactured or distributed by Bayer HealthCare, LLC, owner of the registered trademark ALEVE ® Back & Muscle Pain.
Walgreens Pharmacist Survey
DISTRIBUTED BY:
WALGREEN CO.,
200 WILMOT RD.,
DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2020 Walgreen Co.
L0000531
R1021
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40's carton
Walgreens
Compare to ALEVE ® Back & Muscle Pain active ingredient ††
NDC 0363-0102-15
BACK & MUSCLE PAIN
All Day Pain Relief
NAPROXEN SODIUM CAPSULES, 220 mg (NSAID) / PAIN RELIEVER / FEVER REDUCER
BACK & MUSCLE PAIN
12 HOUR LIQUID GELS
• For temporary relief of minor back & muscle aches & pains
40 LIQUID-FILLED CAPSULES**
(**LIQUID GELS)
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INGREDIENTS AND APPEARANCE
NAPROXEN SODIUM
naproxen sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0102 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. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) LACTIC ACID (UNII: 33X04XA5AT) MANNITOL (UNII: 3OWL53L36A) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color blue (Blue with white text) Score no score Shape CAPSULE Size 25mm Flavor Imprint Code NP1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0102-15 1 in 1 CARTON 03/19/2020 1 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021920 08/02/2019 Labeler - WALGREEN COMPANY (008965063) Registrant - Bionpharma Inc. (079637826) Establishment Name Address ID/FEI Business Operations Patheon Softgels Inc. 002193829 manufacture(0363-0102)