All Day Pain Relief: Package Insert and Label Information

ALL DAY PAIN RELIEF- naproxen sodium tablet, film coated
Family Dollar Services Inc

Active ingredient (in each caplet)

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:

    • headache
    • muscular aches
    • the common cold

    • toothache
    • menstrual cramps

    • backache
    • minor pain of arthritis

  • temporarily reduces fever

Warnings

Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • asthma (wheezing)
  • skin reddening
  • shock
  • blisters
  • rash
  • facial swelling
  • hives

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]
  • take more or for a longer time than directed
  • have 3 or more alcoholic drinks every day while using this product

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

  • 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

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
    • leg swelling
    • chest pain

    • slurred speech
    • trouble breathing

    • weakness in one part or side of body

  • 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 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°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F)

  • see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide

Questions or comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal display panel

COMPARE TO THE ACTIVE INGREDIENT OF ALEVE® CAPLETS

FAMILY
wellness™

NDC 55319-604-12

ALL DAY
PAIN RELIEF

Naproxen Sodium Tablets, 220 mg
Pain Reliever/Fever Reducer (NSAID)

Strength To Last 12 Hours
**CAPSULE-SHAPED TABLETS

100 CAPLETS**

Actual Size

100% SATISFACTION GUARANTEED
OR YOUR MONEY BACK

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

DISTRIBUTED BY:
MIDWOOD BRANDS, LLC
500 VOLVO PARKWAY
CHESAPEAKE, VA 23320

NOT 100% SATISFIED?
Return package and unused product
within 30 days to any Family Dollar store
for a refund (with receipt) or exchange.

This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Aleve® Caplets.50844 REV0517A60412

Family Wellness 44-604
(click image for full-size original)

Family Wellness 44-604

ALL DAY PAIN RELIEF naproxen sodium tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-604
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM 220 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2–ALUMINUM LAKE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color blue Score no score
Shape OVAL Size 12mm
Flavor Imprint Code 44;604
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55319-604-15 1 BOTTLE in 1 CARTON contains a BOTTLE
1 50 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (55319-604-15)
2 NDC:55319-604-12 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
2 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (55319-604-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204872 01/23/2017
Labeler — Family Dollar Services Inc (024472631)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 pack (55319-604)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 manufacture (55319-604), pack (55319-604)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 manufacture (55319-604)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (55319-604)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 117025878 manufacture (55319-604)

Revised: 06/2022 Family Dollar Services Inc

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