NDC 76281-558 Stomach Relief, Maximum Strength

Bismuth Subsalicylate

NDC Product Code 76281-558

NDC CODE: 76281-558

Proprietary Name: Stomach Relief, Maximum Strength 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.

Non-Proprietary Name: Bismuth Subsalicylate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat occasional upset stomach, heartburn, and nausea. It is also used to treat diarrhea and help prevent travelers' diarrhea. It works by helping to slow the growth of bacteria that might be causing the diarrhea. This product should not be used to self-treat diarrhea if you also have a fever or blood/mucus in the stools. These could be signs of a serious health condition. Consult your doctor promptly for proper evaluation and treatment if you have these symptoms. This medication is used under a doctor's direction with other medication to treat stomach ulcers caused by a certain bacteria (Helicobacter pylori). Do not use this medication to self-treat ulcers. Bismuth subsalicylate is a salicylate. Salicylates can cause serious bleeding problems when used alone in patients with ulcers. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

NDC Code Structure

  • 76281 - Aptapharma Inc.

NDC 76281-558-25

Package Description: 177 mL in 1 BOTTLE

NDC Product Information

Stomach Relief, Maximum Strength with NDC 76281-558 is a a human over the counter drug product labeled by Aptapharma Inc.. The generic name of Stomach Relief, Maximum Strength is bismuth subsalicylate. The product's dosage form is suspension and is administered via oral form.

Labeler Name: Aptapharma Inc.

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

Product Type: Human Otc Drug 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.

Stomach Relief, Maximum Strength Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BISMUTH SUBSALICYLATE 1050 mg/30mL

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.

  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • D&C RED NO. 22 (UNII: 1678RKX8RT)
  • D&C RED NO. 28 (UNII: 767IP0Y5NH)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • SODIUM SALICYLATE (UNII: WIQ1H85SYP)
  • XANTHAN GUM (UNII: TTV12P4NEE)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Aptapharma Inc.
Labeler Code: 76281
FDA Application Number: part335 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-30-2020 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: 12-31-2021 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: N 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.

Stomach Relief, Maximum Strength Product Label Images

Stomach Relief, Maximum Strength 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

Allergy alert: Contains salicylate. Do not take if you are■ allergic to salicylates (including aspirin)■ taking other salicylate products

Otc - Active Ingredient

Active ingredient (in each 30 mL dose cup or 2 tablespoons)Bismuth subsalicylate    1050 mg

Otc - Purpose

PurposesBismuth subsalicylate .............. Upset stomach reliever                                                       and antidiarrheal

Indications & Usage

Uses relieves ■ travelers' diarrhea ■ diarrhea■ upset stomach due to overindulgence of food and drinkincluding: ■ heart burn ■ indigestion ■ nausea ■ gas■ belching

Warnings

WarningsReye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should notuse this product. When using this product, if changes inbehavior with nausea and vomiting occur, consult a doctorbecause these symptoms could be an early sign of Reye'ssyndrome, a rare but serious illness.

Otc - Do Not Use

Do not use if you have ■ an ulcer■ a bleeding problem    ■ black or bloody stool

Otc - Ask Doctor

Ask a doctor before use if you have■ fever ■ mucus in stool

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you aretaking any drug for ■ anticoagulation (thinning of the blood)■ diabetes  ■ gout   ■ arthritis

Otc - When Using

When using this product a temporary, but harmless,darkening of the stool and/or tongue may occur

Otc - Stop Use

Slop use and ask a doctor if■ diarrhea lasts more than 2 days■ symptoms get worse or last more than 2 days■ ringing in the ears or loss of hearing occurs

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, ask health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, getmedical help or contact a Poison Control Center right away.

Dosage & Administration

Directions. Shake well before use■ use dose cup or tablespoon (TBSP)■ adults and children 12 years and over: 1 dose (30 mL or 2   TBSP) every 1 hour as needed■ do not exceed 4 doses (120 mL or 8 TBSP) in 24 hours■ use until diarrhea stops but not more than 2 days■ children under 12 years: ask adoctor■ drink plenty of clear fluids to help prevent dehydration   caused by diarrhea

Other Safety Information

Other information■ each 30 mL dose cup contains:sodium 13 mg, salicylate 455 mg■ protect from freezing ■ avoid excessiveheat (over 104ºF or 40ºC) ■ Low sodium

Inactive Ingredient

Inactive ingredients benzoic acid, D&C red #22,D&C red # 28, flavor, purified water, saccharin sodium,salicylic acid, sodium salicylate, xantham gum

Otc - Questions

Questions? 1-877-798-5944

* Please review the disclaimer below.