Label: CARDINAL HEALTH INFANTS GAS RELIEF- simethicone suspension/ drops
- NDC Code(s): 70000-0051-1
- Packager: CARDINAL HEALTH
- 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 October 4, 2023
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
- •
- 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, simply push syringe back until you have reached the described level. Slowly dispense the liquid into your child’s mouth (towards inner cheek).
- •
- 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
- Inactive ingredients
-
Principal Display Panel
*Compare to the active ingredient in Infants’ Mylicon® Drops
NDC 70000-0051-1
Infants’
Gas Relief Drops
Simethicone/Antigas
Dye-free
Non-staining formula
- •
- No Alcohol/No Saccharin
- •
- No Artificial Color
- •
- No Artificial Flavor
1 FL OZ (30 mL) 100 DOSES
Distributed by:
IMPORTANT: Keep this carton for future reference on full labeling.
*This product is not manufactured or distributed by Infirst Healthcare Inc., the distributor of Infants’ Mylicon® Drops.
-
INGREDIENTS AND APPEARANCE
CARDINAL HEALTH INFANTS GAS RELIEF
simethicone suspension/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0051 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:70000-0051-1 1 in 1 CARTON 09/02/2020 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 09/02/2020 Labeler - CARDINAL HEALTH (063997360)
