NDC 55319-352 Regular Strength Acid Reducer

NDC Product Code 55319-352

NDC CODE: 55319-352

Proprietary Name: Regular Strength Acid Reducer 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):
PINK (C48328)
Shape: ROUND (C48348)
Size(s):
8 MM
Imprint(s):
OR;606
Score: 1

NDC Code Structure

  • 55319 - Family Dollar

NDC 55319-352-30

Package Description: 30 TABLET in 1 BOTTLE

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

NDC Product Information

Regular Strength Acid Reducer with NDC 55319-352 is a product labeled by Family Dollar. 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: 312773.

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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Labeler Information

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

Labeler Name: Family Dollar
Labeler Code: 55319
Start Marketing Date: 09-24-2013 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

Ranitidine

Ranitidine is pronounced as (ra ni' ti deen)

Why is ranitidine medication prescribed?
Ranitidine is used to treat ulcers; gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and injury of the...
[Read More]

* Please review the disclaimer below.

Regular Strength Acid Reducer Product Label Images

Regular Strength Acid Reducer 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

Active Ingredient (In Each Tablet)

Ranitidine 75 mg(as ranitidine hydrochloride USP, 84 mg)

Purpose

Acid reducer

Uses

  • •relieves heartburn associated with acid indigestion and sour stomach •prevents heartburn associated with acid indigestion and sour stomach brought on by certain foods and beverages

Warnings

Allergy alert: Do not use if you are allergic to ranitidine or any other acid reducers.

Do Not Use

  • •if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. •with other acid reducers

Ask A Doctor Before Use If You Have

  • •frequent chest pain •frequent wheezing, particularly with heartburn •unexplained weight loss •nausea or vomiting •stomach pain •had heartburn over 3 months. This may be a sign of a more serious condition. •heartburn with lightheadedness, sweating, or dizziness  •chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness

Stop Use And Ask A Doctor If

  • •your heartburn continues or worsens •you need to take this product for more than 14 days

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

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.

Directions

  • •adults and children 12 years and over: •to relieve symptoms, swallow 1 tablet with a glass of water •to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutesbefore eating food or drinking beverages that cause heartburn •can be used up to twice daily (do not take more than 2 tablets in 24 hours) •children under 12 years: ask a doctor

Other Information

  • •TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN •store at 20º-25ºC (68º-77ºF) •avoid excessive heat or humidity •this product is sodium and sugar free

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, hyrpomellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, talc, titanium dioxide

* Please review the disclaimer below.