ALL DAY BACK AND MUSCLE PAIN RELIEF- naproxen sodium tablet, coated

All Day Back and Muscle Pain Relief by

Drug Labeling and Warnings

All Day Back and Muscle Pain Relief by is a Otc medication manufactured, distributed, or labeled by Walmart Inc., TIME CAP LABORATORIES, INC., MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSE

Purposes

Pain reliever/fever reducer

INDICATIONS & USAGE

Uses

temporarily relieves minor aches and pains due to:

• minor pain of arthritis
• muscular aches
• backache
• menstrual cramps
• headache
• toothache
• the common cold

temporarily reduces fever

WARNINGS

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 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

Heart attack and stroke warning: NSAIDs, except aspirin, increase 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.

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 high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
• you are taking a diuretic
• you have problems or serious side effects from taking pain relievers or fever reducers

Ask a doctor or pharmacist before use if you are

• under a doctor's care for any serious condition
• taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
• taking any other drug

When using this product

• take with food or milk if stomach upset occurs

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

you have symptoms of heart problems or stroke:

• chest pain
• trouble breathing
• weakness in one part or side of body
• slurred speech
• leg swelling

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

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in 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 (1-800-222-1222).

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other information

• each tablet contains: sodium 20 mg
• store at 20-25ºC (68-77ºF).
• avoid high humidity and excessive heat above 40°C (104°F).

INACTIVE INGREDIENT

Inactive ingredients

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

QUESTIONS

Questions or comments? Call 1-877-290-4008

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALL DAY BACK AND MUSCLE PAIN RELIEF 
naproxen sodium tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79903-609
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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE (UNII: FZ989GH94E)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

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: 79903-609-09	1 in 1 CARTON	12/15/2023
1		90 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 79903-609-20	1 in 1 CARTON	12/15/2023
2		200 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	12/15/2023

Labeler - Walmart Inc. (051957769)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	manufacture(79903-609)