Ana-dent

Ana-dent
SPL v1
SPL
SPL Set ID 04721306-2850-4e0a-9dd9-7cabb575f3c7
Route
ORAL
Published
Effective Date 2020-05-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naproxen (220 mg)
Inactive Ingredients
Silicon Dioxide Fd&c Blue No. 2 Hypromellose 2910 (5 Mpa.s) Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol 8000 Povidone K30 Titanium Dioxide Talc

Identifiers & Packaging

Marketing Status
ANDA Active Since 2020-05-15

Description

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/ fever reducer


Medication Information

Indications and Usage

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

Purpose

Pain reliever/ fever reducer

Dosage and 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

Description

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

Section 42229-5

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

Section 50565-1

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.

Section 51727-6

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

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.

Packaging

Drug Facts

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

Questions Or Comments?

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

Active Ingredient (in Each Tablet)

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

*nonsteroidal anti-inflammatory drug


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

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.

Section 51727-6 (51727-6)

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

Purpose

Pain reliever/ fever reducer

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.

Packaging

Drug Facts

Other Information (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

Questions Or Comments? (Questions or comments?)

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

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

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

*nonsteroidal anti-inflammatory drug


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)