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 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
rash
blisters

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 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.

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.

24 COUNT 608R

50 COUNT 608R

EZ OPEN 100 COUNT 608R

100 COUNT 608RM CRC

608R 200 CT LABEL

270 CT 608R LABEL

600CT 608R

INGREDIENTS AND APPEARANCE

ALL DAY PAIN RELIEF 
naproxen sodium tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-9608
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)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
MAGNESIUM STEARATE (UNII: 70097M6I30)
FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	144
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-9608-42	24 in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2019
2	NDC: 0363-9608-05	50 in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2019
3	NDC: 0363-9608-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2019
4	NDC: 0363-9608-20	200 in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2019
5	NDC: 0363-9608-27	270 in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2019
6	NDC: 0363-9608-61	600 in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2019

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(0363-9608)