Quita Cólicos ®

Quita Cólicos ®
SPL v8
SPL
SPL Set ID d4b0fa36-5925-4a6f-b3c9-0c785503976f
Route
ORAL
Published
Effective Date 2019-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (20 mg)
Inactive Ingredients
Citric Acid Monohydrate Hypromellose, Unspecified Maltitol Water Sodium Benzoate Sodium Citrate, Unspecified Form Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-03-18

Description

Drug Facts

Purpose

Antigas


Medication Information

Purpose

Antigas

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

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

Questions

1-800-858-3889

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

Active Ingredient (in Each 0.3 Ml)

Simethicone 20 mg

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)


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Purpose

Antigas

Questions

1-800-858-3889

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 (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 (Inactive ingredients)

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

Active Ingredient (in Each 0.3 Ml) (Active ingredient (in each 0.3 mL))

Simethicone 20 mg

Principal Display Panel 30 Ml Bottle Box (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)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)