Drugplain

Infants Gas Relief Drops 20 mg/.3mL

Simethicone · EMULSION · DOLGENCORP INC

1 Recall on Record
Plain English

Infants Gas Relief Drops is a emulsion containing simethicone at 20 mg/.3mL, taken oral. Manufactured by DOLGENCORP INC.

Key Facts

Brand Name
Infants Gas Relief Drops
Generic Name
Simethicone
NDC Code (Product)
55910-790
Manufacturer
DOLGENCORP INC
Strength
20 mg/.3mL
Dosage Form
EMULSION
Route
ORAL
Marketing Status
Application #
M002
Marketing Start
01/14/2020

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
diarrhoea79 reports
vomiting70 reports
abdominal pain67 reports
dyspnoea66 reports
pain58 reports
pyrexia58 reports
anaemia56 reports
asthenia52 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods

Dosage & Administration

Directions shake well before using find right dose on chart below. if possible, use weight to dose; otherwise use age. Only use the enclosed syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child. remove cap and insert syringe into the prescribed level. pull syringe up until filled to the prescribed level. If you pass the prescribed level, simply push syringe back until you have reached the desired level. slowly dispense the liquid into your child’s mouth (towards inner chick). 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. cool water, infant formula or other suitable liquids replace cap tightly to maintain child resistance mL= milliliter Age (yr) Weight (lb) Dose( mL) infants under 2 under 24 0.3 children over 2 over 24 0.6

Warnings

Warnings Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any sign or symptoms

Frequently Asked Questions

What is Infants Gas Relief Drops used for?

Infants Gas Relief Drops contains Simethicone. It is a emulsion taken oral. Consult your doctor for specific uses.

Is Infants Gas Relief Drops a controlled substance?

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

What is the generic name for Infants Gas Relief Drops?

The generic name for Infants Gas Relief Drops is Simethicone. There are 12 other brand versions of Simethicone.

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

The NDC (National Drug Code) for Infants Gas Relief Drops 20 mg/.3mL is 55910-790, listed by DOLGENCORP INC.