FDA Label for Simethicone
View Indications, Usage & Precautions
Simethicone Product Label
The following document was submitted to the FDA by the labeler of this product Advance Pharmaceutical 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 chewable tablet)
Simethicone 125 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 physician
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 631-981-4600, 8.30 am – 4.30 pm EST Monday - Friday
Package Label
NDC: 17714-040-60 – 60 CHEWABLE TABLETS
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