OTC Medication Information: All Day Relief

ALL DAY RELIEF- naproxen sodium tablet
Preferred Pharmaceuticals Inc.

Active ingredient(s)

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

Purpose

Pain reliever/ fever reducer

Use(s)

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.

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

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 doctor if

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

Pregnancy/Breastfeeding

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.

Keep out of reach of children

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

Directions

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

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

Other information

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

Inactive ingredients

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

Distributed by

Rugby Laboratories
Livonia, MI 48150 USA

Repackaged By: Preferred Pharmaceuticals Inc.

Principal Display Panel

Container label caplets (capsule shaped tablets)

Naproxen Sodium Tablets 220mg
(click image for full-size original)
ALL DAY RELIEF
naproxen sodium tablet, coated tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-9971(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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 1000
POVIDONE K12
TITANIUM DIOXIDE
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 141
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-9971-2 20 TABLET in 1 BOTTLE None
2 NDC:68788-9971-3 30 TABLET in 1 BOTTLE None
3 NDC:68788-9971-4 40 TABLET in 1 BOTTLE None
4 NDC:68788-9971-6 60 TABLET in 1 BOTTLE None
5 NDC:68788-9971-9 90 TABLET in 1 BOTTLE None
6 NDC:68788-9971-1 100 TABLET in 1 BOTTLE None
7 NDC:68788-9971-8 120 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090545 05/06/2015
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK (68788-9971)

Revised: 12/2018 Preferred Pharmaceuticals Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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