ANA-DENT PAIN RELIEF- naproxen sodium tablet, film coated 
Belmora LLC

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Ana-Dent PAIN RELIEF

Drug Facts

Active ingredient (in each tablet)

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/ fever reducer

Uses ■ temporarily relieves minor aches and pain due to: ■ headache ■ muscular aches ■ toothache ■ the common cold ■ backache ■ menstrual cramps ■ minor pain of arthritis

■ temporarily reduces fever

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.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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

each tablet contains: sodium 20 mg

■ store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F)

■ see end flap for expiration date and lot number

Inactive ingredients colloidal silicon dioxide, FD & C Blue#2 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide, talc

Questions or comments?

Call 1-888-779-2877 M-F 9AM-5PM EST

For toothaches

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

Distributed by Belmora LLC, 2011 Crystal Dr. Suite 400 Arlington, VA 22202

www.anadentusa.com

Made in India

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Packaging

Flx701

ANA-DENT PAIN RELIEF 
naproxen sodium tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27854-701
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN220 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorblue (light blue) Scoreno score
ShapeROUND (Circular) Size10mm
FlavorImprint Code J;67
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27854-701-011 in 1 CARTON05/15/2020
124 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20549705/15/2020
Labeler - Belmora LLC (112753244)

Revised: 5/2020
Document Id: 5ac02446-13da-43d5-9647-fe469294acec
Set id: 04721306-2850-4e0a-9dd9-7cabb575f3c7
Version: 1
Effective Time: 20200518
 
Belmora LLC