ALL DAY PAIN RELIEF- naproxen sodium tablet

ALL DAY PAIN RELIEF by

Drug Labeling and Warnings

ALL DAY PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by SPIRIT PHARMACEUTICALS LLC, MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 :
• backache
• headache
• menstrul cramps
• minor pain of arthritis
• muscular aches
• the common cold
• toothache
• temporarily reduces fever

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

If pregnant or breast feeding, ask a health profession 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 complication during the delivery.

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

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

Inactive ingredients

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

Questions or comments?

1-888-333-9792

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY

SPIRIT PHARMACEUTICALS, LLC.

RONKONKOMA, NY 11779

MADE IN INDIA

PRINCIPAL DISPLAY PANEL - 15 COUNT BOTTLE CARTON

VALUMEDS™

SEE NEW WARNINGS INFORMATION

Compare to the active ingredient

in ALEVE®*

ALL DAY PAIN RELIEF

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

STRENGTH TO LAST 12 HOURS

15 TABLETS (OVAL-SHAPED)

INGREDIENTS AND APPEARANCE

ALL DAY PAIN RELIEF 
naproxen sodium tablet

Product 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)