Infant's Gas Relief Drops

Infant's Gas Relief Drops
SPL v5
SPL
SPL Set ID 05eadb73-4468-4dae-a67b-133d893feed2
Route
ORAL
Published
Effective Date 2024-09-12
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 Microcrystalline Cellulose Polysorbate 60 Potassium Sorbate Water Sodium Benzoate Sorbitan Monostearate Sorbitol Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-04

Description

Simethicone 20 mg

Purpose

Antigas


Medication Information

Purpose

Antigas

Description

Simethicone 20 mg

Uses

relieves the symptoms referred to as gas

Section 50565-1

Keep this and all medications out of the reach of children

Section 51945-4

Warnings

In case of overdose seek medical help immediately or contact Poison Control Center right away (800)222-1222

For adverse reactions contact the FDA at www.fda.gov or 1(888)463-6332

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 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 over 2

over 24

0.6 mL

Other Information
  • TAMPER-EVIDENT :Do not use if printed seal under 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 strawberry, Microcrystalline cellulose, Polysorbate 60, Potassium sorbate, Purified water, Sodium benzoate, Sorbitan monostearate, Sorbitol solution, Xanthan gum.

Questions Or Comments ?

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Active Ingredient (in Each 0.3 Ml)

Simethicone 20 mg


Structured Label Content

Uses

relieves the symptoms referred to as gas

Section 50565-1 (50565-1)

Keep this and all medications out of the reach of children

Section 51945-4 (51945-4)

Purpose

Antigas

Warnings

In case of overdose seek medical help immediately or contact Poison Control Center right away (800)222-1222

For adverse reactions contact the FDA at www.fda.gov or 1(888)463-6332

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 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 over 2

over 24

0.6 mL

Other Information (Other information)
  • TAMPER-EVIDENT :Do not use if printed seal under 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 strawberry, Microcrystalline cellulose, Polysorbate 60, Potassium sorbate, Purified water, Sodium benzoate, Sorbitan monostearate, Sorbitol solution, Xanthan gum.

Questions Or Comments ? (Questions or comments ?)

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)