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 Select Brand Dist.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

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

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
• have 3 or more alcoholic drinks every day while using this product
• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• 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 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, or kidney disease
• you have problems or serious side effects from taking pain relievers or fever reducers
• you have asthma
• you are taking a diuretic

Ask a doctor or pharmacist before use if you are

• under a doctor’s care for any serious condition
• 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 the following signs of stomach bleeding:
  • feel faint
  • have bloody or black stools
  • vomit blood
  • 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
• redness or swelling is present in the painful area
• any new symptoms appear
• you have difficulty swallowing
• it feels like the pill is stuck in your throat

If pregnant or breast-feeding,

ask a health professional 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 complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

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 caplet every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 caplets within the first hour
  • do not exceed 2 caplets in any 8- to 12-hour period
  • do not exceed 3 caplets in a 24-hour period
• children under 12 years: ask a doctor

Other information

• each caplet contains: sodium 20 mg
• store at 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat above 40°C (104°F).
• read all warnings and directions before use. Keep carton.

Inactive ingredients

croscarmellose sodium, FD&C blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, titanium dioxide

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

ALL DAY PAIN RELIEF

Naproxen Sodium Tablets, 220 mg

Pain Reliever / Fever Reducer (NSAID)

*Compare to the active ingredient in ALEVE®

CAPLETS**

(**Capsule-Shaped Tablets)

This product is not manufactured or distributed by Bayer HealthCare, LLC.,distributor of Aleve®.

DO NOT USE IF INNER SEAL UNDER BOTTLE CAP PRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by:

SELECT BRAND DISTRIBUTORS

Pine Bluff, AR 71603 USA

AC (870 )535-3635

Product Label

Select Brand All Day Relief

INGREDIENTS AND APPEARANCE

ALL DAY PAIN RELIEF 
naproxen sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15127-168
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	12mm
Flavor		Imprint Code	I7
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15127-168-24	1 in 1 BOX	06/30/2016
1		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079096	06/30/2016

Labeler - Select Brand Dist. (012578514)