Label: QUITA COLICOS GAS RELIEF DROPS- simethicone liquid
- NDC Code(s): 24286-1533-8
- Packager: DLC Laboratories, 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 15, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 0.3 mL)
- Purpose
- Uses
- Warnings
-
Directions
- shake well before using
- find right dose on chart. If possible, use weight to dose; otherwise, use age.
- only use the enclosed dropper. Fill dropper to the recommended dosage level and dispense liquid slowly into baby's mouth, toward the inner cheek.
- all dosages may be repeated as needed, after meals and at bedtime or as directed by a doctor
- do not exceed 12 doses per day
- dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids
- clean dropper well after each use and replace original cap
mL = milliliter
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- Questions
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box
-
INGREDIENTS AND APPEARANCE
QUITA COLICOS GAS RELIEF DROPS
simethicone liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24286-1533 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 CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MALTITOL (UNII: D65DG142WK) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24286-1533-8 1 in 1 BOX 03/18/2014 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 03/18/2014 Labeler - DLC Laboratories, Inc. (093351930) Establishment Name Address ID/FEI Business Operations DLC Laboratories, Inc. 093351930 MANUFACTURE(24286-1533) , LABEL(24286-1533)
