CALMADOL PAIN RELIEVER- naproxen sodium tablet

CALMADOL PAIN RELIEVER by

Drug Labeling and Warnings

CALMADOL PAIN RELIEVER by is a Otc medication manufactured, distributed, or labeled by Grandall Distributing Co., Inc., Weeks & Leo Co., Inc., MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients (in each tablet)

Naproxen sodium 220 mg

(naproxen 200 mg)(NSAID)*

Purpose

Pain reliever/

fever reducer

Uses

■ temporarily relieves minor aches and pains due to:

■ headache ■ common cold ■ muscular aches

■backache ■ toothache ■ menstrual cramps

■minor pain of arthritis

■temporarily reduces fever

PREGNANCY OR BREAST FEEDING

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 right away.

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 ■ 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

■ 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 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 problems or serious side effects from taking pain relievers or fever reducers

■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

■ you are taking a diuretic

■ you have asthma

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

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:

Each tablet contains sodium 20 mg. Store at 20-25 C (68-77ºF) Avoid high humidity and excessive heat above 40ºC (104ºF). Keep Carton.

Questions

If you have questions of a medical nature, please conact your pharmacist, doctor or health care professional.

SPL UNCLASSIFIED SECTION

Distributed by: Grandall Distributing Co., Inc. Glendale, CA 91204-2707

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline, cellulose, polyethylene glycol, povidone, titanium dioxide

Package Labeling

CALMADOL

PAIN RELIEVER

FEVER REDUCER

Naproxen Sodium Tablets

220 mg (NSAID)

24 TABLETS

INGREDIENTS AND APPEARANCE

CALMADOL PAIN RELIEVER 
naproxen sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48201-007
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)

Product Characteristics
Color	blue	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	141
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48201-007-24	1 in 1 BOX	03/31/2015
1		24 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090545	03/31/2015

Labeler - Grandall Distributing Co., Inc. (044428324)

Establishment
Name	Address	ID/FEI	Business Operations
Weeks & Leo Co., Inc.		005290028	repack(48201-007)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	manufacture(48201-007)