BACK AND MUSCLE PAIN- naproxen tablet, coated

BACK AND MUSCLE PAIN by

Drug Labeling and Warnings

BACK AND MUSCLE PAIN 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 INGREDIENTS

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

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 first dose you may take 2 tablets with in 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

KEEP OUT OF REACH OF CHILDREN

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

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.

24 CT

100 CT

INGREDIENTS AND APPEARANCE

BACK AND MUSCLE PAIN 
naproxen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-9609
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: 0363-9609-42	24 in 1 BOTTLE; Type 0: Not a Combination Product	06/05/2019
2	NDC: 0363-9609-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/03/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090545	06/03/2019

Labeler - WALGREENS (008965063)

Registrant - TIME CAP LABORATORIES, INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LTD		925822975	manufacture(0363-9609)