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  5. Label Information: Simethicone

FDA Label for Simethicone

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 INGREDIENTS
    9. QUESTIONS OR COMMENTS
    10. PACKAGE LABEL

Simethicone 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 chewable tablet)

Simethicone 80 mg


Purpose



Antiflatulent


Uses



relieves

  • bloating
  • pressure
  • discomfort of gas which can be caused by certain foods or air swallowing

Warnings



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


Directions



  • chew thoroughly 1 to 2 tablets as needed after meals and at bed time.
  • do not exceed 6 tablets per day unless directed by a doctor

Other Information



  • store at room temperature 15-30 °C (59-86 °F)
  • protect from moisture

Inactive Ingredients



dextrose, dipac sugar, maltodextrin, peppermint flavor, sorbitol, stearic acid


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:  54738-518-01

– 100 CHEWABLE

image description - IMG 4684

image description - IMG 4684

TABLETS


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