NDC 70005-008 All Day Pain Relief

NDC Product Code 70005-008

NDC CODE: 70005-008

Proprietary Name: All Day Pain Relief What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Product Characteristics

Color(s):
BLUE (C48333 - LIGHT BLUE)
Shape: OVAL (C48345)
Size(s):
12 MM
Imprint(s):
220
Score: 1

NDC Code Structure

NDC 70005-008-02

Package Description: 2 POUCH in 1 POUCH > 2 TABLET in 1 POUCH

NDC 70005-008-25

Package Description: 25 POUCH in 1 BOX > 2 TABLET in 1 POUCH

NDC 70005-008-50

Package Description: 50 POUCH in 1 BOX > 2 TABLET in 1 POUCH

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

All Day Pain Relief with NDC 70005-008 is a product labeled by We Care Distributor Inc.. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 849574.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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 Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: We Care Distributor Inc.
Labeler Code: 70005
Start Marketing Date: 09-30-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Information for Patients

Naproxen

Naproxen is pronounced as (na prox' en)

Why is naproxen medication prescribed?
Prescription naproxen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints),...
[Read More]

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All Day Pain Relief Product Label Images

All Day Pain Relief Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Otc - Purpose

Active ingredients (in each tablet)PurposesNaproxen Sodium 220 mg (naproxen 200 mg) (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

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 ■ blistersIf 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

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

Otc - Pregnancy Or Breast Feeding

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.

Otc - Keep Out Of Reach Of Children

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 doseAdults and children  ■ take 1 tablet every 8 to 12 hours while symptoms last 12 years and older  ■ 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 periodChildren 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)

Inactive Ingredients

FD&C blue#2 aluminum lake, hypromellose 2910, maize starch, microcrystalline cellulose, polyethylene glycol, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide

* Please review the disclaimer below.