Label: NAPROXEN- naproxen sodium tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 61010-4410-0, 61010-4410-1, 61010-4410-2 - Packager: Safetec of America, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 20, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- 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
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
- 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 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
- under a doctor's care for any serious condition
- taking any other drug
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
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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 under12 years - ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel – Pouch Label
Safetec
of America, Inc.DO NOT USE IF POUCH IS TORN OR DAMAGED
Manufactured for Safetec of America, Inc.
Buffalo NY 14215
Naproxen Sodium Tablets USP, 220 mg (NSAID)**
Pain reliever/fever reducer
STRENGTH TO LAST 12 HOURS
Contains no Ingredient made from a
gluten-containing grain (wheat, barley, or rye)1 Tablet
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Principal Display Panel – 50-Pouch Carton Label
Safetec®
of America, Inc.Compare to the active ingredient
in Aleve® Tablets*NDC 61010-4410-1
STRENGTH TO LAST 12 HOURS
Naproxen Sodium
Tablets USP, 220 mg (NSAID)**
Pain Reliever/Fever Reducer
PUSH TO OPEN
Dispense through
openingContains no ingredient made from a gluten-containing
grain (wheat, barley, or rye)- Relieves minor aches and pains
- Fever reducer
- Lasts up to 12 hours
TAMPER EVIDENT UNIT DOSE POUCHES
DO NOT USE IF POUCH IS TORN OR DAMAGED
50 Pouches
1 Tablet per Pouch
-
Principal Display Panel – 100-Pouch Carton Label
Safetec®
of America, Inc.Compare to the active ingredient
in Aleve® Tablets*NDC 61010-4410-2
STRENGTH TO LAST 12 HOURS
Naproxen Sodium
Tablets USP, 220 mg (NSAID)**
Pain Reliever/Fever Reducer
Contains no ingredient made from a gluten-containing
grain (wheat, barley, or rye)- Relieves minor aches and pains
- Fever reducer
- Lasts up to 12 hours
PUSH TO OPEN
Dispense
through
openingTAMPER EVIDENT UNIT DOSE POUCHES
DO NOT USE IF POUCH IS TORN OR DAMAGED
100 Pouches
1 Tablet per Pouch
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INGREDIENTS AND APPEARANCE
NAPROXEN
naproxen sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61010-4410 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 Microcrystalline Cellulose (UNII: OP1R32D61U) Starch, Corn (UNII: O8232NY3SJ) Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2) Povidone K30 (UNII: U725QWY32X) Water (UNII: 059QF0KO0R) Stearic acid (UNII: 4ELV7Z65AP) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) Product Characteristics Color blue (blue) Score no score Shape ROUND (ROUND) Size 9mm Flavor Imprint Code 220 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61010-4410-0 1 in 1 POUCH; Type 0: Not a Combination Product 01/20/2020 2 NDC:61010-4410-1 50 in 1 CARTON 01/20/2020 2 NDC:61010-4410-0 1 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:61010-4410-2 100 in 1 CARTON 01/20/2020 3 NDC:61010-4410-0 1 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091353 01/20/2020 Labeler - Safetec of America, Inc. (874965262)