Hst Infants Gas Relief

Hst Infants Gas Relief
SPL v5
SPL
SPL Set ID e47eca0a-4678-4c72-97f0-144e6aa06520
Route
ORAL
Published
Effective Date 2023-05-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-05-01

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.

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 anddispense liquid slowly into baby’s mouth, toward the inner cheek 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 on bottle
Age (years) Weight (lbs) Dose
infants (under 2) under 24 0.3 mL

children (2 and over)

24 and over 0.6 mL

Package Label

Other Information
  • TAMPER-EVIDENT: Do not use if foil seal under the cap is broken or punctured.
  • 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

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

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

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 anddispense liquid slowly into baby’s mouth, toward the inner cheek 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 on bottle
Age (years) Weight (lbs) Dose
infants (under 2) under 24 0.3 mL

children (2 and over)

24 and over 0.6 mL

Package Label

Other Information (Other information)
  • TAMPER-EVIDENT: Do not use if foil seal under the cap is broken or punctured.
  • 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

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

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)