Rapidol Stomach Relief Liquid
FDA Label NDC 55758-331

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Rapidol Stomach Relief (NDC 55758-331). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient & purposes, otc - purpose, uses, warnings, do not use if you have, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are taking any drug for, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Drug Facts

Active Ingredient & Purposes

Otc - Purpose

Active ingredient
(in each 30 mL dose cup or 2 tablespoons)

Purposes
Bismuth subsalicylate 525 mg.................Upset stomach reliever and antidiarrhea

Uses

relieves

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence of food and drink including:
  • heart burn
  • indigestion
  • nausea
  • gas
  • belching

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: contains salicylate. Do not take if you are

  • allergic to salicylates (including aspirin)
  • taking other salicylate products

Do Not Use If You Have

  • an ulcer
  • a bleeding problem
  • black or bloody stool

Ask A Doctor Before Use If You Have

  • fever
  • mucus in stool

Ask A Doctor Or Pharmacist Before Use If You Are Taking Any Drug For

  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis

When Using This Product

a temporary, but harmless, darkening of the stool and/or tongue may occur.

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

If Pregnant Or Breast Feeding,

ask 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

  • 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 1/2 to 1 hour or every hour as needed
  • do not exceed 8 doses (240 mL or 16 TBSP) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • children under 12 years: ask adoctor



Other Information

  • each 30 mL dose contains: magnesium45 mg, sodium 13 mg, salicylate 256 mg
  • protect from freezing
  • avoid excessive heat (over 104°F or 40°C)
  • low sodium

Inactive Ingredients

benzoic acid, D&C red #22, D&C red #28, flavor, magnesium aluminum silicate, purified water, saccharin sodium, salicylic acid, sodium salicylate, xanthan gum

Questions?

1-866-359-3478 (9 AM - 5 PM EST) or pharmadel.com

Principal Display Panel

NDC 55758-331-08

Rapidol Stomach Relief 8 FL OZ

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