Label: QUALITY CHOICE INFANTS NON-STAINING GAS RELIEF- simethicone solution/ drops
- NDC Code(s): 63868-112-01
- Packager: Chain Drug Marketing Association Inc.
- 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 July 29, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT (in each 0.3 mL)
- PURPOSE
- USE(S)
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
DIRECTIONS
- shake well before using
- all dosages may be repeated as needed, after meals and at bedtime
- fill enclosed dropper to recommended dosage level
- dispense liquid slowly into baby's mouth, toward the inner cheek
- may mix with 1 oz. of cool water, infant formula or other suitable liquids
- clean dropper after each use and close the bottle to maintain child resistance
age (yr) weight (lb) dose infants under 2 under 24 0.3 mL children over 2 over 24 0.6 mL - OTHER INFORMATION
- INACTIVE INGREDIENTS
-
PRINCIPAL DISPLAY PANEL
NDC 63868-112-01
QC
Quality Choice
*Compare to the Active Ingredient in Mylicon®
Non-Staining Infants' Drops
Infants' Non-Staining
Gas Relief Drops
Antigas
Simethicone 20 mg
Fast Relief of Gas Symptoms
No Artificial Flavor
Alcohol Free
Dye Free
Gentle & Safe**
**Use only as directed;
do not exceed 12 doses per day.
1 FL OZ (30mL)
-
INGREDIENTS AND APPEARANCE
QUALITY CHOICE INFANTS NON-STAINING GAS RELIEF
simethicone solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-112 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 BENZOIC ACID (UNII: 8SKN0B0MIM) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE (off-white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-112-01 1 in 1 CARTON 07/29/2022 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 07/29/2022 Labeler - Chain Drug Marketing Association Inc. (011920774)