1. Home
  2. Labeler Index
  3. Richmond Pharmaceuticals, Inc
  4. 54738-102
  5. Label Information: Pepto Relief

FDA Label for Pepto Relief

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENT
    9. QUESTIONS OR COMMENTS
    10. PACKAGE LABEL

Pepto Relief Product Label

The following document was submitted to the FDA by the labeler of this product Richmond Pharmaceuticals, Inc. 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



.


Active Ingredient



(in each tablet)

Bismuth subsalicylate 262 mg


Purpose



Anti-diarrheal/Upset stomach reliever


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 products

    Do not use

  • If you have bloody or black stool
  • If you have an ulcer or bleeding problem

    Ask a doctor before use if you have

  • Fever
  • Mucus in the stool

    Ask a doctor or pharmacist before use if you are

  • taking any drug for
  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

    when 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 days

    If 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 77 mg, salicylate 102 mg
  • store at 15°-30°C (59°-86°F)
  • protect from moisture

Inactive Ingredient



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


Questions Or Comments



TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Call 804-270-4498, 8.30 am – 4.30 pm EST Monday - Friday


Package Label



NDC:  54738-102-30

– 30 TABLETS

NDC: 54738-102-48- 48  TABLETS

IMG_4675 - IMG 4675

IMG_4675 - IMG 4675


* Please review the disclaimer below.