Label: ANA-DENT PAIN RELIEF- naproxen sodium tablet, film coated
- NDC Code(s): 27854-701-01
- Packager: Belmora LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 18, 2020
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each tablet)
- Purpose
- INDICATIONS & USAGE
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Warnings
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: ■ shock ■ facial swelling ■ asthma (wheezing) ■ hives ■ skin reddening ■ blisters ■ rash
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
■ have had stomach ulcers or bleeding problems
■ take blood thinning (anticoagulant) or steroid drug
■ are age 60 or older
■ take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
■ take more or for a longer time than directed
■ have 3 or more alcoholic drinks every day while using this product.
Do not use ■ right before or after heart surgery ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer
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 asthma
■ you have high blood pressure, heart disease, liver cirrhosis or kidney disease
■ you have a problems or serious side effects from taking pain relievers or fever reducers
■ you are taking a diuretic
Ask a doctor or pharmacist before use if you are
■ under a doctor's care for any serious condition
■ 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 the following signs 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 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, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
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DOSAGE & ADMINISTRATION
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 to12 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 INGREDIENT
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
ANA-DENT PAIN RELIEF
naproxen sodium tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:27854-701 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) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B) POVIDONE K30 (UNII: U725QWY32X) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color blue (light blue) Score no score Shape ROUND (Circular) Size 10mm Flavor Imprint Code J;67 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:27854-701-01 1 in 1 CARTON 05/15/2020 1 24 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 ANDA205497 05/15/2020 Labeler - Belmora LLC (112753244)