NDC 21695-639 Peptic Relief

NDC Product Code 21695-639

NDC CODE: 21695-639

Proprietary Name: Peptic 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):
PINK (C48328)
Shape: ROUND (C48348)
Size(s):
18 MM
Imprint(s):
LOGO;045
Score: 1

NDC Code Structure

  • 21695 - Rebel Distributors Corp

NDC 21695-639-30

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

Peptic Relief with NDC 21695-639 is a product labeled by Rebel Distributors Corp. 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: 308761.

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.

  • D&C RED NO. 27 (UNII: 2LRS185U6K)
  • CALCIUM CARBONATE (UNII: H0G9379FGK)
  • DEXTROSE (UNII: IY9XDZ35W2)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SORBITOL (UNII: 506T60A25R)

Product Labeler Information

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

Labeler Name: Rebel Distributors Corp
Labeler Code: 21695
Start Marketing Date: 12-30-2011 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: 12-31-2017 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

Bismuth Subsalicylate

Bismuth Subsalicylate is pronounced as (biz muth) (sub sa lis' i late)

Why is bismuth subsalicylate medication prescribed?
Bismuth subsalicylate is used to treat diarrhea, heartburn, and upset stomach in adults and children 12 years of age and older. Bismuth subsalicylate is in a class of med...
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* Please review the disclaimer below.

Peptic 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

Active Ingredient

Bismuth Subsalicytate 262mg

Purpose

Anti-diarrheal/Upset stomach reliever

Keep Out Of Reach Of Children

In case of overdose,, get medical help or contact a Poison Control Center right away.

Uses

* Controls diarrhea* Relieves upset stomach due to overindulgence in food or drink

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.Allergy Alert: Do not take if you are* allergic to salicylates (including aspirin)* taking other salicylate productsDo not use* if you have bloody or black stool* if you have an ulcer or bleeding problemAsk a doctor before use if you have* fever* mucus in the stool

Drug Facts

Ask a doctor or pharmacist before use if you are taking any drug for* anticoagulation (thinning the blood)* diabetes* gout* arthritisWhen using this product a temporary, but harmless, darkening of the stool and/or tongue may occur.Stop use and ask a doctor if* symptoms get worse* ringing in the ears or loss of hearing occurs* diarrhea lasts more than 2 daysIf pregnant or breast-feeding, ask a health professional before use.

Directions

* drink plenty of clear fluids to help prevent dehydration caused by diarrhea* repeat dosage every 1/2 to 1 hour as needed* do not take more than 8 doses in 24 hours* use until diarrhea stops but not more than 2 days* adults and children 12 years and over: 2 tablets* children under 12 years: ask a doctor

Other Information

* each tablet contains: calcium 77mg salicylate 102mg* store at 15°-30°C (59°-86°F)* protect from moisture

Inactive Ingredients

D&C red #27 (al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol

* Please review the disclaimer below.