All Day Relief

ALL DAY RELIEF — naproxen sodium tablet
REMEDYREPACK INC.

OTC — ACTIVE INGREDIENT

Naproxen Sodium Tablets, USP
220 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

OTC — PURPOSE

Pain reliever/ fever reducer

INDICATIONS & USAGE

temporarily relieves minor aches and pain due to:

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

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 a 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.

OTC — DO NOT USE

  • if you have ever had an allergic reaction to any other pain reliever / fever reducer
  • right before or after heart surgery

OTC — ASK DOCTOR

  • 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

OTC — ASK DOCTOR/PHARMACIST

  • under a doctor’s care for any serious condition
  • taking any other drug

OTC — WHEN USING

  • 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

OTC — STOP USE

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have a stomach pain that dose 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 sluck in your throat
  • redness or swelling is present in the painful area
  • any new symptoms appear

OTC — PREGNANCY OR BREAST FEEDING

ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of the pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

OTC — KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

  • do not more than directed
  • the smallest effective dose should be used
  • do not take longer than 10 days, unless directred by a doctor (see Warnings)
  • 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 within the first hour
  • do not exceed 2 tablets in any 8 to 12 hour period
  • do not exceed 3 tablets in a 24 hours period

children under 12 years:
  • ask a doctor

STORAGE AND HANDLING

  • Store at 20-25o C (68-77o F). Avoid high humidity and excessive heat above 400 C (1040 F)

SPL UNCLASSIFIED

  • each tablet contain: sodium 20 mg
  • Questions or comments? 1-800-645-2158

INACTIVE INGREDIENT

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

SPL UNCLASSIFIED

Rugby Laboratories
Livonia, MI 48150 USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: All Day Relief

GENERIC: Naproxen Sodium Tablet, coated

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 61786-171-02

ACTIVE INGREDIENT(S):

  • NAPROXEN SODIUM 220mg in 1

INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • POLYETHYLENE GLYCOL 1000
  • MAGNESIUM STEARATE
  • POVIDONE K12
  • SILICON DIOXIDE
  • CROSCARMELLOSE SODIUM
  • FD&C BLUE NO. 2
  • HYPROMELLOSES
  • TITANIUM DIOXIDE

COLOR: blue

SHAPE: ROUND

SCORE: No score

SIZE: 10 mm

IMPRINT: 141

PACKAGING: 30 in 1 BLISTER PACK

MM1
(click image for full-size original)
MM2
(click image for full-size original)
ALL DAY RELIEF
naproxen sodium tablet, coated tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-171(NDC:0536-1023)
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
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 1000
MAGNESIUM STEARATE
POVIDONE K12
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
HYPROMELLOSES
TITANIUM DIOXIDE
Product Characteristics
Color blue Score no score
Shape ROUND (TABLET) Size 10mm
Flavor Imprint Code 141
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61786-171-02 30 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090545 03/09/2015
Labeler — REMEDYREPACK INC. (829572556)

Revised: 03/2015 REMEDYREPACK INC.

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