Label: ALL DAY PAIN RELIEF- naproxen sodium tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 68210-0030-1 - Packager: SPIRIT PHARMACEUTICALS LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 26, 2019
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
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WARNINGS
Warnings
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- asthma (wheezing)
- blisters
- facial swelling
- hives
- rash
- shock
- skin reddening
- If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains a non steroidal anti-inflammatory drug(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
- if you have ever had an allergic reaction to any other pain reliever / fever reducer
- right before or after surgery
Ask a doctor before use if
- the stomach bleeding warning applies to you
- you have a history of stomach problems,such as a heartburn
- you have a high blood pressure, heart disease, liver cirrhosis or kidney disease
- you are taking a diuretic
- you have problems or serious side effects taking pain relievers or fever reducers
- you have asthma
Ask a doctor or pharmacist before use if you are
- under a doctor 's care for any serious conditions
- taking any other drug
When using this product
- take with food or milk if stomach upset occurs
- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stop use and ask a doctor if
- you experience any of following sign of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- you have difficulty swallowing
- it feel 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 under 12 years:
- ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 15 COUNT BOTTLE CARTON
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INGREDIENTS AND APPEARANCE
ALL DAY PAIN RELIEF
naproxen sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-0030 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape OVAL Size 18mm Flavor Imprint Code 144 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-0030-1 1 in 1 CARTON 04/11/2018 1 15 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090545 04/11/2018 Labeler - SPIRIT PHARMACEUTICALS LLC (179621011) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 925822975 manufacture(68210-0030)