Infants Gas relief 20 mg/.3mL

Simethicone · SOLUTION/ DROPS · Topco Associates, LLC

1 Recall on Record

Plain English

Infants Gas relief is a solution/ drops containing simethicone at 20 mg/.3mL, taken oral. Manufactured by Topco Associates, LLC.

Key Facts

Brand Name: Infants Gas relief
Generic Name: Simethicone
NDC Code (Product): 36800-119
Manufacturer: Topco Associates, LLC
Strength: 20 mg/.3mL
Dosage Form: SOLUTION/ DROPS
Route: ORAL
Marketing Status
Application #: M002
Marketing Start: 03/01/2013

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. It is a solution/ drops taken oral. Consult your doctor for specific uses.

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 36800-119, listed by Topco Associates, LLC.

Product NDC

36800-119

Package NDC

36800-119-09

Other Simethicone Brands

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

Data from openFDA · Public domain (CC0 1.0)