ALL DAY PAIN RELIEF- naproxen sodium tablets, 220 mg tablet

All Day Pain Relief by

Drug Labeling and Warnings

All Day Pain Relief by is a Otc medication manufactured, distributed, or labeled by HealthLife of USA LLC, Granules India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each caplet)                        Purpose

Naproxen Sodium 220 mg

(naproxen 200mg) (NSAID)* ....................Pain reliever / Fever reducer

*nonsteroidal anti-inflammatory drug

Uses

■ temporarily relieves minor aches and pains due to:

  ■ minor pain of arthritis ■ muscular aches ■ backache ■ headache

  ■ menstrual cramps ■ toothache ■ the common cold

■ 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

■ 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

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 are taking a diuretic

■ you have problems or serious side effects from taking pain relievers or fever reducers

■ you have asthma

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 ■ vomit blood ■ have bloody or black stools

  ■ 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

■ 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 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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 information

■ each tablet contains: sodium 20 mg

■ store at 20-25° C (68-77° F).

■ avoid high humidity and excessive heat above 40° C (104° F)

■ read all product information before using

■ TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

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

Questions or comments?

Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST or www.healthlifeofusa.com

PRINCIPAL DISPLAY PANEL

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Compare to the Active Ingredients in Aleve®.

ALL DAY PAIN RELIEF

Naproxen Sodium Tablets, 220 mg

INGREDIENTS AND APPEARANCE

ALL DAY PAIN RELIEF 
naproxen sodium tablets, 220 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69517-109
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)	NAPROXEN	220 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
POVIDONE K30 (UNII: U725QWY32X)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE (Light Blue)	Score	no score
Shape	OVAL (Capsule-Shaped)	Size	12mm
Flavor		Imprint Code	220
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69517-109-25	25 in 1 BOX	04/07/2016
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 69517-109-50	50 in 1 BOX	04/07/2016
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 69517-109-02	2 in 1 POUCH	04/07/2016
3		2 in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 69517-109-04	400 in 1 BOTTLE	04/07/2016
4	NDC: 69517-109-01	100 in 1 BOTTLE
4	NDC: 69517-109-24	24 in 1 BOTTLE
4		1 in 1 CARTON; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091353	09/30/2011

Labeler - HealthLife of USA LLC (079656178)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India Limited		918609236	manufacture(69517-109)