ALL DAY PAIN RELIEF- naproxen sodium tablet, coated

ALL DAY PAIN RELIEF by

Drug Labeling and Warnings

ALL DAY PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by WALGREENS, TIME CAP LABORATORIES INC, MARKSANS PHARMA LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Naproxen Sodium Tablets, USP
220 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

INACTIVE INGREDIENT

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

PURPOSE

Pain reliever/ fever reducer

INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

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

WARNINGS

Allergy alerts: 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 an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

are age 60 or older
have bad stomach ulcers or bleeding problems
take blood thinning (anticoagulant) or steroid drug
take other drug 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.

Heart attack and stroke warning: NSAID's, except aspirin, increases the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a poison control center right away.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALL DAY PAIN RELIEF 
naproxen sodium tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-6099
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POVIDONE (UNII: FZ989GH94E)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)

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: 0363-6099-05	50 in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2019
2	NDC: 0363-6099-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2019
3	NDC: 0363-6099-20	200 in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090545	06/30/2019

Labeler - WALGREENS (008965063)

Registrant - TIME CAP LABORATORIES INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LTD		925822975	manufacture(0363-6099)