NDC 55651-264 Pepbis Regular

NDC Product Code 55651-264

NDC 55651-264-01

Package Description: 237 mL in 1 BOTTLE

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

NDC Product Information

Pepbis Regular with NDC 55651-264 is a product labeled by Kc Pharmaceuticals, Inc.. The generic name of Pepbis Regular is . The product's dosage form is and is administered via form.

Labeler Name: Kc Pharmaceuticals, 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.

  • FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • METHYLCELLULOSE (400 CPS) (UNII: O0GN6F9B2Y)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • SODIUM SALICYLATE (UNII: WIQ1H85SYP)
  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

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

Labeler Name: Kc Pharmaceuticals, Inc.
Labeler Code: 55651
Start Marketing Date: 03-04-2004 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: 12-31-2018 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 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’.

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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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Pepbis Regular Product Label Images

Pepbis Regular 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 Ingredients

Bismuth subsalicylate, 262 mg

Purpose

Bismuth subsalicylate - Upset stomach reliever and Antidiarrheal

Keep Out Of Reach Of Children.

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

Uses

  • Upset stomachindigestionnauseaheartburndiarrhea

Warnings

  • Reye's Syndrome: Children and teenagers who have or are recovering from chicken pox, flu symptoms, or flu should NOT use this product.  If nausea, vomiting or fever occur, consult a doctor because these symptoms could be an early sign of Reye Syndrom, a rare but serious illness.Allergy Alert: do not take this product if you are allergic to salicylates (including aspirin) unless directed by a doctor.Do not use for diarrhea on children under 3 years of ageAsk a doctor or a pharmacist before use if you are taking prescription medicines for anticoagulation (thinning of the blood), diabetes, gout or arthritis.Stop use and ask a doctor ifyou are taking this product with other salicylate-containing preparations (such as aspirin) and ringing in the ears occurs.  This product contains salicylate.diarrhea is accompanied by a high fever or continues for more than 2 daysother symptoms last more than 2 weeks

Directions

  • Shake well before useFor convenience, use the dosage cupadults and children 12 yrs and over2 Tbsp or 30 mLchildren 9 to under 12 years1 Tbsp or 15 mLchildren 6 to under 9 years2 tsp or 10 mLchildren 3 to under 6 years1 tsp or 5 mLchildren under 3 yearsconsult a doctorRepeat above dosage every 1/2 to 1 hour as needed to a maximum of 8 doses in a 24-hour period

Inactive Ingredients

FD and C Red No. 3, FD and C Red No. 40, flavor, magnesium aluminum silicate, methylcellulose, saccharin sodium, salicylic acid, sodium salicylate, and water

Other Information

  • Do not use if imprinted safety seal around the dosage cup and bottle is broken or missingeach tablespoon (15 mL) contains: sodium 1 mgeach tablespoon (15 mL) contains: salicylate 130 mgsugar freelow in sodiumavoid excessive heat (over 104oF or 40oC)protect from freezingmay cause a temporary and harmless darkening of the tongue or stool

If Pregnant Or Breast-Feeding

Ask a health professional before use.

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