Drugplain

Infants Gas relief 20 mg/.3mL

Simethicone · SOLUTION/ DROPS · Harris Teeter, LLC

1 Recall on Record
Plain English

Infants Gas Relief contains simethicone, a medication that helps break up gas bubbles in the stomach and intestines to relieve bloating, discomfort, and gas in infants. This over-the-counter liquid drops are given by mouth and work locally in the digestive tract without being absorbed into the bloodstream.

Key Facts

Brand Name
Infants Gas relief
Generic Name
Simethicone
NDC Code (Product)
69256-520
Manufacturer
Harris Teeter, LLC
Strength
20 mg/.3mL
Dosage Form
SOLUTION/ DROPS
Route
ORAL
Marketing Status
Application #
M002
Marketing Start
02/05/2025

Recall History

1 Recall on Record
Class II09/18/2019

GCP Laboratories Inc

Microbial Contamination of Non-Sterile Product.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

nausea106 reports
fatigue83 reports
diarrhoea80 reports
vomiting72 reports
abdominal pain67 reports
dyspnoea66 reports
pain59 reports
pyrexia58 reports
anaemia57 reports
asthenia53 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

USE(S) relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods

Dosage & Administration

DIRECTIONS shake well before using all dosages may be repeated as needed, after meals and at bedtime fill enclosed dropper to recommended dosage level dispense liquid slowly into baby's mouth, toward the inner cheek may mix with 1 oz. of cool water, infant formula or other suitable liquids clean dropper after each use and close the bottle to maintain child resistance age (yr) weight (lb) dose infants under 2 under 24 0.3 mL children over 2 over 24 0.6 mL

Warnings

WARNINGS When using this product do not exceed 12 doses per day

Frequently Asked Questions

What is Infants Gas relief used for?

Infants Gas Relief contains simethicone, a medication that helps break up gas bubbles in the stomach and intestines to relieve bloating, discomfort, and gas in infants. This over-the-counter liquid drops are given by mouth and work locally in the digestive tract without being absorbed into the bloodstream.

Is Infants Gas relief a controlled substance?

Infants Gas relief is not classified as a controlled substance by the DEA.

What is the generic name for Infants Gas relief?

The generic name for Infants Gas relief is Simethicone. There are 11 other brand versions of Simethicone.

What is the NDC code for Infants Gas relief 20 mg/.3mL?

The NDC (National Drug Code) for Infants Gas relief 20 mg/.3mL is 69256-520, listed by Harris Teeter, LLC.