Simethicone 125 mg/1
Simethicone · CAPSULE, LIQUID FILLED · Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Simethicone is an over-the-counter medication taken by mouth that helps relieve bloating, gas, and discomfort caused by excess gas in the digestive tract. It works by breaking up gas bubbles so they can be more easily eliminated from your body.
Key Facts
- Brand Name
- Simethicone
- Generic Name
- Simethicone
- NDC Code (Product)
53345-033- Manufacturer
- Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
- Strength
- 125 mg/1
- Dosage Form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Marketing Status
- Application #
- M002
- Marketing Start
- 01/28/2015
Recall History
Belmora LLC
Defective Container: Product lacks tamper evident breakaway band on cap.
RIJ Pharmaceutical LLC
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Plastikon Healthcare LLC
Microbial Contamination of Non-Sterile Products
GCP Laboratories Inc
Microbial Contamination of Non-Sterile Product.
Novartis Consumer Health
Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Plastikon Healthcare LLC
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Tarmac Products, Inc.
Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point.
Plastikon Healthcare LLC
Microbial Contamination of Non-Sterile Products.
Plastikon Healthcare LLC
CGMP Deviations: Failure to properly investigate failed microbial testing.
Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals
Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count outside of specifications and E. Coli contamination.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
USE(S) relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
Dosage & Administration
DIRECTIONS • drink plenty of clear fluids to help prevent dehydration caused by diarrhea • take only on an empty stomach (1 hour before or 2 hours after a meal) • take with a full (8 oz.) glass of water • find right dose on chart below. If possible, use weight to dose; otherwise, use age. adults and children 12 years and over 2 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours children 9-11 years (60-95 lbs) 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours children 6-8 years (48-59 lbs) 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets in 24 hours children 2-5 years (34 to 47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use
Warnings
WARNINGS Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide hydrochloride Heart alert: Taking more than directed can cause serious heart problems or death
Frequently Asked Questions
What is Simethicone used for?
Simethicone is an over-the-counter medication taken by mouth that helps relieve bloating, gas, and discomfort caused by excess gas in the digestive tract. It works by breaking up gas bubbles so they can be more easily eliminated from your body.
Is Simethicone a controlled substance?
Simethicone is not classified as a controlled substance by the DEA.
What is the generic name for Simethicone?
The generic name for Simethicone is Simethicone. There are 11 other brand versions of Simethicone.
What is the NDC code for Simethicone 125 mg/1?
The NDC (National Drug Code) for Simethicone 125 mg/1 is 53345-033, listed by Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd..
Other Simethicone Dosages
Other Simethicone Brands
See all →- Gas Relief180 mg/172090-015
- Infants20 mg/.3mL0536-1303
- Meijer Max Gas 30ct750 mg/179481-0095
- Gas Relief Simethicone 180mg Softgel180 mg/184324-015
- Gas Relief125 mg/184324-022
- Gas Relief - Cherry Flavor125 mg/111673-066
- Kroger Extra Strength Gas Relief125 mg/130142-481
- Infants Gas relief20 mg/.3mL36800-119
- Gas Relief125 mg/136800-122
- PHAZYME180 mg/10132-0208
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)