QUITA COLICOS GAS RELIEF DROPS- simethicone liquid

QUITA COLICOS Gas RELIEF Drops by

Drug Labeling and Warnings

QUITA COLICOS Gas RELIEF Drops by is a Otc medication manufactured, distributed, or labeled by DLC Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

• 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

• do not use if printed bottle wrap is missing or broken
• store at room temperature
• do not freeze
• see bottom panel for lot number and expiration date

Inactive ingredients

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

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INFANTS (under 2 years): 0.3 mL

CHILDREN (over 2 years): 0.6 mL

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

Questions

1-800-858-3889

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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)

INGREDIENTS AND APPEARANCE

QUITA COLICOS GAS RELIEF DROPS 
simethicone liquid

Product 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)