NDC 59556-946 Acid Reducer

NDC Product Code 59556-946

NDC 59556-946-25

Package Description: 1 BOTTLE in 1 CARTON > 50 TABLET in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing certification is expired.

NDC Product Information

Acid Reducer with NDC 59556-946 is a product labeled by Strides Pharma Inc. The generic name of Acid Reducer is . The product's dosage form is and is administered via form.

Labeler Name: Strides Pharma Inc

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

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)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Labeler Information

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

Labeler Name: Strides Pharma Inc
Labeler Code: 59556
Start Marketing Date: 12-31-2020 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: 12-31-2020 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: E 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

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 150 mg (as ranitidine hydrochloride USP, 168 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 eating or drinking certain foods and beverages

Warnings

Allergy alert: Do not use if you are allergic to ranitidine or 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

  • 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  frequent chest pain  frequent wheezing, particularly with heartburn  unexplained weight loss  nausea or vomiting  stomach pain  kidney diseaseAsk a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Stop Use And Ask A Doctor If

  • Your heartburn continues or worsensyou 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 right away.

Directions

  • Adults and children 12 years and over:to relieve symptoms, swallow 1 tablet with a glass of waterto prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburncan 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 20° - 25° C (68° - 77° F)avoid excessive heat or humiditythis product is sodium and sugar free

Inactive Ingredients

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

Questions?

  • Call 1-877-244-9825Tips for managing heartburnDo not lie flat or bend over soon after eatingDo not eat late at night, or just before bedtimeCertain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetablesEat slowly and do not eat big mealsIf you are overweight, lose weightIf you smoke, quit smokingRaise the head of your bedWear loose fitting clothing around your stomachRead the directions and warnings before use. Keep the carton. It contains important information including tips for managing heartburn.Manufactured by: Strides Pharma Science Ltd. Puducherry - 605 014, India. PON/DRUGS/16 13 4193 Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816 Revised: 09/2019

* Please review the disclaimer below.