Label: INFANTS GAS RELIEF DROPS- simethicone emulsion
- NDC Code(s): 55910-790-01
- Packager: DOLGENCORP INC
- 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 July 5, 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
-
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 any 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 prescribed level.
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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 (towards inner chick).
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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
-
Principal Display Panel
NDC 55910-790-01
*Compare to active ingredient in infant’s Mylicon® Gas Relief*
Infants'
Gas Relief
Simethicone Drops / Anti-gas
- •
- Dye- free
- •
- Non-staining formula
Fast, effective relief of infants’ gas symptoms
1 FL. OZ. (30 mL)
100 doses
DISTRIBUTED BY: OLD EAST MAIN CO.
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072
100% SATISFACTION GUARANTEED!
(888) 309-9030
*This product is not manufactured or distributed by Infirst Healthcare Inc., the distributor of Infants’ Mylicon® Gas Relief.
- IMPORTANT: Keep this carton for future reference on full labeling
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INGREDIENTS AND APPEARANCE
INFANTS GAS RELIEF DROPS
simethicone emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-790 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-790-01 1 in 1 CARTON 01/14/2020 1 30 mL in 1 BOTTLE; 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 01/14/2020 Labeler - DOLGENCORP INC (068331990)
