QUITA COLICOS GAS RELIEF DROPS- simethicone liquid 
DLC Laboratories, Inc.

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.

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QUITA CÓLICOS® GAS RELIEF DROPS

Drug Facts

Active ingredient (in each 0.3 mL)

Simethicone 20 mg

Purpose

Antigas

Uses

Relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods.

Warnings

Keep out of reach of children. In case of overdose get medical help or contact a Poison Control Center right away.

Directions

mL = milliliter

Other information

Inactive ingredients

citric acid, hydroxypropyl methylcellulose, maltitol, natural flavor, purified water USP, sodium benzoate, sodium citrate, xanthan gum

INFANTS (under 2 years): 0.3 mL

Image

CHILDREN (over 2 years): 0.6 mL

AGE (years)WEIGHT (lbs.)DOSE
INFANTS under 2Under 24 lbs.0.3 mL
CHILDREN over 2More than 24 lbs.0.6 mL

Questions

1-800-858-3889

Manufactured by:
De La Cruz Products
A Division of DLC Laboratories, Inc.
Paramount, CA 90723 USA

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box

De La Cruz®
Baby

Gas
Relief Drops

Gotas Quita Cólicos®

Simethicone
— ANTIGAS —

Safe for newborns & infants
No alcohol, No dyes, No saccharin

Up To 100 Doses

NATURAL
CHERRY FLAVOR

1 FL OZ (30 mL)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box
QUITA COLICOS GAS RELIEF DROPS 
simethicone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24286-1533
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24286-1533-81 in 1 BOX03/18/2014
130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33203/18/2014
Labeler - DLC Laboratories, Inc. (093351930)
Establishment
NameAddressID/FEIBusiness Operations
DLC Laboratories, Inc.093351930MANUFACTURE(24286-1533) , LABEL(24286-1533)

Revised: 7/2019
Document Id: 9d72de57-4d2e-4489-a9c5-a0f36c24bca1
Set id: d4b0fa36-5925-4a6f-b3c9-0c785503976f
Version: 5
Effective Time: 20190715
 
DLC Laboratories, Inc.