1. Home
  2. Labeler Index
  3. Physicians Total Care, Inc.
  4. 54868-2898
  5. Label Information: Peptic Relief Original Strength

FDA Label for Peptic Relief Original Strength

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH 15 ML TABLESPOON)
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. OTHER
    17. PRINCIPAL DISPLAY PANEL

Peptic Relief Original Strength Product Label

The following document was submitted to the FDA by the labeler of this product Physicians Total Care, 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.

Active Ingredient (In Each 15 Ml Tablespoon)



Bismuth subsalicylate 262 mg


Purposes



Upset stomach reliever/antidiarrheal


Uses



relieves

  • travelers’ diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
  • heartburn
  • indigestion
  • nausea
  • gas
  • belching
  • fullness

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
  • bloody or black stool

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.


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)


Directions



  • shake well before use
  • for accurate dosing, use dose cup
  • adults and children 12 years and over: 1 dose (2 Tbsp or 30 mL) every 1/2 to 1 hour as needed
  • do not exceed 8 doses (16 Tbsp or 240 mL) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other Information



  • each Tbsp contains: magnesium 5 mg, potassium 5 mg and sodium 5 mg
  • salicylate 123 mg
  • protect from freezing
  • sugar free
  • low sodium
  • store at 20°-25°C (68°-77°F)
  • does not meet USP requirements for pH
  • for health information visit www.more-info.info

Inactive Ingredients



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


Questions Or Comments?



1-800-719-9260


Other



Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma        74146


Principal Display Panel



Original Strength

Stomach Relief

Bismuth Subsalicylate 262 mg

Antidiarrheal/Upset Stomach Reliever

Protective Coating Action

Soothing Relief for 5 Symptoms:

  • Upset Stomach
  • Indigestion
  • Heartburn
  • Nausea
  • Diarrhea

    • Compare to active ingredient of Pepto-Bismol®

    NDC 54868-2898-0
    237 mL
    Stomach Relief Label - 2898

    Stomach Relief Label - 2898


    Stomach Relief Label


* Please review the disclaimer below.