Gnp Infant Drops

Gnp Infant Drops
SPL v4
SPL
SPL Set ID 7d3c3cc6-b0a2-620d-e053-2a91aa0a159b
Route
ORAL
Published
Effective Date 2012-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (20 mg)
Inactive Ingredients
Carboxymethylcellulose Sodium Anhydrous Citric Acid Maltitol Cellulose, Microcrystalline Water Sodium Benzoate Sodium Citrate Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-06-01

Description

Simethicone 20 mg

Purpose

Antigas


Medication Information

Purpose

Antigas

Description

Simethicone 20 mg

Use

relieves the symptoms referred to as gas

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Warnings



Directions
  • shake well before using
  • all dosages may be repeated as needed, after meals and at bedtime, or as directed by a physician
  • do not exceed 12 doses per day
  • fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby’s mouth, toward inner cheek
  • dosage can also be mixed with 1 oz. of cool water, infan formula or other suitable liquids
  • clean dropper well after each use and replace original cap on bottle
Age (years) Weight (lbs) Dose
infants (under 2) under 24 0.3 mL
children (over 2) 24 and over 0.6 mL

Package Label

Other Information
  • store at room temperature
  • do not freeze
  • see bottom panel for lot number and expiration date
Inactive Ingredients

carboxymethylcellulose sodium, citric acid, flavor, maltitol, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate, xanthan gum.

Questions Or Comments?

1-800-540-3765

Active Ingredient (in Each 0.3 Ml)

Simethicone 20 mg


Structured Label Content

Use

relieves the symptoms referred to as gas

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

Warnings



Directions
  • shake well before using
  • all dosages may be repeated as needed, after meals and at bedtime, or as directed by a physician
  • do not exceed 12 doses per day
  • fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby’s mouth, toward inner cheek
  • dosage can also be mixed with 1 oz. of cool water, infan formula or other suitable liquids
  • clean dropper well after each use and replace original cap on bottle
Age (years) Weight (lbs) Dose
infants (under 2) under 24 0.3 mL
children (over 2) 24 and over 0.6 mL

Package Label (package Label)

Other Information (Other information)
  • store at room temperature
  • do not freeze
  • see bottom panel for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

carboxymethylcellulose sodium, citric acid, flavor, maltitol, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate, xanthan gum.

Questions Or Comments? (Questions or comments?)

1-800-540-3765

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

Simethicone 20 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)