![QUALITY CHOICE INFANTS DYE FREE GAS RELIEF (SIMETHICONE) EMULSION [CHAIN DRUG MARKETING ASSOCIATION]](https://medic.hrt.org//dailymed/images/6b8a1eaa-6f8c-4ab6-81e0-9d64f6f1b5e4/766DF30MYLFC.jpg)
| NDC | 63868-696-30 |
| Set ID | 6b8a1eaa-6f8c-4ab6-81e0-9d64f6f1b5e4 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | CHAIN DRUG MARKETING ASSOCIATION |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART332 |
- Active ingredient (in each 0.3 mL)
- Purpose
- Uses
- Warnings
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Directions
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- shake well before using
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- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
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- only use the enclosed syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child.
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- remove cap and insert syringe into the bottle
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- 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).
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- all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician.
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- do not exceed 12 doses per day.
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- dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
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- replace cap tightly to maintain child resistance
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- mL = milliliter
Age (yr)
Weight (lb)
Dose (mL)
infants under 2
under 24
0.3
children over 2
over 24
0.6
- Other information
- Inactive ingredients
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Principal Display Panel
NDC# 63868-696-30
QUALITY CHOICE®
*Compare to the Active Ingredient in Infants’ Mylicon®
Infants’ Dye-Free Gas Relief Drops
Relieves Gas Symptoms
Simethicone Antigas 20 mg
No Saccharin
No Artificial Colors
No Artificial Flavor
Non-Staining
1 Fl. OZ (30ml)
100 Doses
100% QC SATISFACTION GUARANTEED
Distributed by: C.D.M.A. Inc. ©
43157 W 9 Mile Rd
Novi, MI 48375
Questions: 248-449-9300
*This product is not manufactured or distributed by Infirst Healthcare Inc., the distributor of Infants’ MYLICON® Drops.
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INGREDIENTS AND APPEARANCE
QUALITY CHOICE INFANTS DYE FREE GAS RELIEF
simethicone emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-696 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 20 mg in 0.3 mL Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYSORBATE 60 (UNII: CAL22UVI4M) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) SORBITOL (UNII: 506T60A25R) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE (white to off white, opaque) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-696-30 1 in 1 CARTON 12/17/2018 1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part332 12/17/2018 Labeler - CHAIN DRUG MARKETING ASSOCIATION (011920774)
