Indications and uses
relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods
Quality Choice Infants Dye Free Gas Relief Drops
- Manufacturer
- QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
- Effective date
- 2025-08-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:11:31
Label at a glance#
ProductQuality Choice Infants Gas Relief Dye Free
Active ingredientDIMETHICONE, UNSPECIFIED
Label structure8 sections
Dosage and administration
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 other syringe, dropper, spoon or dosing device when giving this medicine to your child. remove cap and insert syringe into the bottle pull syringe up until filled to the prescribed level. If you pass the prescribed level, simply push syringe back until you have reac...
Storage and handling
tamper evident: do not use if printed seal under cap is broken or missing store at room temperature do not freeze see bottom panel for lot number and expiration date
Contacts and useful links#
Websitewww.qualitychoice.com
www.qualitychoice.com
www.qualitychoice.comLabel contents#
Full prescribing information#
Active ingredient (in each 0.3 mL)
Simethicone 20 mg
Purpose
Antigas
Uses
relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods
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 signs or symptoms.
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 other syringe, dropper, spoon or dosing device when giving this medicine to your child.
- remove cap and insert syringe into the bottle
- 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 (toward inner cheek).
- After use, clean syringe with warm, soapy water. Do not subject to high heat.
- 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 |
Other information
- tamper evident: do not use if printed seal under cap is broken or missing
- store at room temperature
- do not freeze
- see bottom panel for lot number and expiration date
Inactive ingredients
carboxymethylcellulose sodium, citric acid, flavors, microcrystalline cellulose, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum
Questions or comments?
Call 1-866-467-2748
Principal Display Panel
NDC# 83324-335-01
QUALITY CHOICE ®
*Compare to the Active Ingredient in Infants’ Mylicon® Drops
Infants’ Gas Relief Drops
Dye-Free
Simethicone / Antigas
No Saccharin
No Artificial Colors
No Artificial Flavor
Non-Staining Formula
1 Fl. OZ (30ml)
100 Doses
100% QC SATISFACTION GUARANTEED
Distributed by: C.D.M.A. Inc.
Novi, MI 48375
Questions: 800-935-2362
*This product is not manufactured or distributed by Infirst Healthcare Inc., the distributor of Infants’ MYLICON ®Drops.
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIMETHICONE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83324-335-01 | Quality ChoiceInfants Gas Relief Dye Free | 30 mL in 1 BOTTLE, DROPPER | EMULSION | 30 | 1 | |
| 83324-335-01 | Quality ChoiceInfants Gas Relief Dye Free | 1 in 1 CARTON | EMULSION | 1 | 1 |
Products#
Every source-derived product name is available through these pages.
- Quality Choice Infants Gas Relief Dye Free
- Simethicone
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
- ANHYDROUS CITRIC ACID
- MICROCRYSTALLINE CELLULOSE
- POLYSORBATE 60
- POTASSIUM SORBATE
- WATER
- SODIUM BENZOATE
- SORBITAN MONOSTEARATE
- SORBITOL
- XANTHAN GUM
- DIMETHICONE, UNSPECIFIED
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 83324-335 | 83324-335-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED | K679OBS311 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYSORBATE 60 | CAL22UVI4M | IACT |
| POTASSIUM SORBATE | 1VPU26JZZ4 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITAN MONOSTEARATE | NVZ4I0H58X | IACT |
| SORBITOL | 506T60A25R | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| DIMETHICONE, UNSPECIFIED | 92RU3N3Y1O | ACTIB |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Quality Choice Infants Gas Relief Dye Free | SIMETHICONE | QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) | 841b85ef-2ac8-4dac-8659-cffb7e1b1e05 | 2025-08-23 | Warnings | 83324-335-01 83324-335 83324033501 3d02651a-0fb7-6954-e063-6294a90aa9ef 841b85ef-2ac8-4dac-8659-cffb7e1b1e05 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.