Label: BEST CHOICE- simethicone suspension/ drops
- NDC Code(s): 63941-709-01
- Packager: BEST CHOICE (VALU MERCHANDISERS COMPANY)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 21, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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, simply push syringe back until you have reached the described level. Slowly dispense the liquid into your child’s mouth (towards 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
Best Choice®
COMPARE TO THE ACTIVE INGREDIENT IN INFANTS’ MYLICON® DROPS*
NDC 63941-709-01
INFANTS’
Gas Relief Drops
SIMETHICONE Anti-gas 20 mg
Dye-free
Non-staining formula
- •
- No Alcohol/No Saccharin
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- No Artificial Color
- •
- No Artificial Flavor
1 FL OZ (30 mL) 100 DOSES
Best Choice 100% Guaranteed
PROUDLY DISTRIBUTED BY:
VALU MERCHANDISERS, CO.
5000 KANSAS AVE
KANSAS CITY, KS 66106
BEST CHOICE
*This product is not manufactured or distributed by McNeil Consumer Pharmaceuticals Co., the distributor of Infants’ MYLICON® Drops.
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INGREDIENTS AND APPEARANCE
BEST CHOICE
simethicone suspension/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63941-709 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 (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 PINK Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63941-709-01 1 in 1 CARTON 04/10/2019 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 04/10/2019 Labeler - BEST CHOICE (VALU MERCHANDISERS COMPANY) (868703513)
