Major Infant Gas Relief

Major Infant Gas Relief
SPL v7
SPL
SPL Set ID fa869550-a0a8-4359-8d23-d2d178090549
Route
ORAL
Published
Effective Date 2021-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-12-07 Until 2021-06-30

Description

Simethicone 20 mg

Purpose

Antigas

How Supplied

Product: 17856-5894 NDC: 17856-5894-1 10 mL in a CUP NDC: 17856-5894-4 1.2 mL in a DOSE PACK / 60 in a CASE


Medication Information

Purpose

Antigas

How Supplied

Product: 17856-5894

NDC: 17856-5894-1 10 mL in a CUP

NDC: 17856-5894-4 1.2 mL in a DOSE PACK / 60 in a CASE

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, infant formula or other suitable liquids
  • clean dropper well after each use and replace original cap


Age (years) Weight (lbs) Dose
infants (under 2)

under 24

0.3 mL

children (2 and over)

24 and over

0.6 mL

Other Information
  • TAMPER-EVIDENT: Do not use if foil seal under cap is broken or missing.
  • store at room temperature
  • do not freeze

  • see bottom panel for lot number and expiration date

Inactive Ingredients

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

Questions Or Comments?

(800)616-2471

Active Ingredient (in Each 0.3 Ml)

Simethicone 20 mg

Infants Gas Relief (simethicone) Suspension/ Drops


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, infant formula or other suitable liquids
  • clean dropper well after each use and replace original cap


Age (years) Weight (lbs) Dose
infants (under 2)

under 24

0.3 mL

children (2 and over)

24 and over

0.6 mL

How Supplied (HOW SUPPLIED)

Product: 17856-5894

NDC: 17856-5894-1 10 mL in a CUP

NDC: 17856-5894-4 1.2 mL in a DOSE PACK / 60 in a CASE

Other Information (Other information)
  • TAMPER-EVIDENT: Do not use if foil seal under cap is broken or missing.
  • store at room temperature
  • do not freeze

  • see bottom panel for lot number and expiration date

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

(800)616-2471

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

Simethicone 20 mg

Infants Gas Relief (simethicone) Suspension/ Drops (INFANTS GAS RELIEF (SIMETHICONE) SUSPENSION/ DROPS)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)