Label: CVS HEALTH INFANT GAS RELIEF- simethicone suspension/ drops
- NDC Code(s): 69842-979-15
- Packager: CVS PHARMACY
- Category: HUMAN OTC DRUG LABEL
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 September 13, 2023
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- 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 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 passed 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 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
-
Principal Display Panel
CVS Health™
Compare to the active ingredient in Little Remedies® Gas Relief*
50 Infant Doses
NDC# 69842-979.15
Gas Relief
SIMETHICONE 20 mg
ANTIGAS
DYE FREE
Actual Bottle size on Side Panel
0.5 FL OZ (15 mL)
*This product is not manufactured or distributed by Medtech Products Inc., the distributor of Little Remedies® Gas Relief Drops.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
@ 2020 CVS/pharmacy CVS.com®
1-800-SHOP CVS
V-31765
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IMPORTANT: Keep this Carton for future reference on full labeling
Package Label 50 Infant Doses
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INGREDIENTS AND APPEARANCE
CVS HEALTH INFANT GAS RELIEF
simethicone suspension/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-979 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 BERRY (natural) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-979-15 1 in 1 CARTON 12/23/2019 1 15 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 12/23/2019 Labeler - CVS PHARMACY (062312574)