Drugplain

Little Remedies Gas Relief Drops 20 mg/.3mL

simthicone · LIQUID · Medtech Products Inc.

2 Recalls on Record
Plain English

Little Remedies Gas Relief Drops contain simethicone, an over-the-counter medication taken by mouth that helps relieve gas, bloating, and discomfort caused by excess gas in the stomach and intestines. This product is commonly used for infants and young children to ease digestive discomfort.

Key Facts

Brand Name
Little Remedies Gas Relief Drops
Generic Name
simthicone
NDC Code (Product)
63029-103
Manufacturer
Medtech Products Inc.
Strength
20 mg/.3mL
Dosage Form
LIQUID
Route
ORAL
Marketing Status
Application #
M002
Marketing Start
01/04/2010

Recall History

2 Recalls on Record
Class II03/07/2019

Medtech Products, Inc.

Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.

TerminatedVoluntary: Firm initiated
Class II05/28/2024

Denison Pharmaceuticals, LLC

cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

decreased appetite2 reports
dyspnoea2 reports
hypersomnia2 reports
asthenia1 reports
cardiomegaly1 reports
choking1 reports
cough1 reports
hypoxia1 reports
pneumonia1 reports
respiratory syncytial virus infection1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Relieves discomfort of infant gas frequently caused by excessive swallowing of air or certain formulas or food.

Dosage & Administration

Directions shake well before using only use enclosed syringe; fill to prescribed level and dispense liquid slowly into child’s mouth, toward inner cheek all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician. Do not exceed 12 doses per day. dosage can also be mixed with 1 oz of cool water, infant formula or other suitable liquids for best results, clean syringe after each use and replace original cap If possible, use weight to determine dose; otherwise use age. mL = milliliter s Age (yrs) Weight (lbs) Dose Newborns & Infants under 2 years Under 24 0.3 mL Children 2 years and over 24 and over 0.6 mL

Warnings

Warnings Keep out of reach of children.

Frequently Asked Questions

What is Little Remedies Gas Relief Drops used for?

Little Remedies Gas Relief Drops contain simethicone, an over-the-counter medication taken by mouth that helps relieve gas, bloating, and discomfort caused by excess gas in the stomach and intestines. This product is commonly used for infants and young children to ease digestive discomfort.

Is Little Remedies Gas Relief Drops a controlled substance?

Little Remedies Gas Relief Drops is not classified as a controlled substance by the DEA.

What is the generic name for Little Remedies Gas Relief Drops?

The generic name for Little Remedies Gas Relief Drops is simthicone. There are no other listed brand versions of simthicone.

What is the NDC code for Little Remedies Gas Relief Drops 20 mg/.3mL?

The NDC (National Drug Code) for Little Remedies Gas Relief Drops 20 mg/.3mL is 63029-103, listed by Medtech Products Inc..

Product NDC

63029-103

Package NDC

63029-103-02

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)