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  5. Label Information: Rapidol Stomach Relief

FDA Label for Rapidol Stomach Relief

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT & PURPOSES
    3. OTC - PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE IF YOU HAVE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE TAKING ANY DRUG FOR
    9. WHEN USING THIS PRODUCT
    10. SLOP USE AND ASK A DOCTOR IF
    11. IF PREGNANT OR BREAST FEEDING,
    12. KEEP OUT OF REACH OF CHILDREN.
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS?
    17. DISTRIBUTED BY:
    18. PRINCIPAL DISPLAY PANEL

Rapidol Stomach Relief Product Label

The following document was submitted to the FDA by the labeler of this product Pharmadel Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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