infant's gas relief

infant's gas relief
SPL v1
SPL
SPL Set ID 9f2733ad-e623-4dc4-b616-498eb3bd648a
Route
oral
Published
Effective Date 2013-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (20 mg)
Inactive Ingredients
sodium benzoate citric acid monohydrate hypromelloses carbomer homopolymer type b (allyl sucrose crosslinked) sucralose vanillin sodium citrate water

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2013-02-03
Purpose

Anti-gas

Description

Drug Facts

Medication Information

Uses

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

Purpose

Anti-gas

Directions
  • shake well before using
  • all doses 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 be mixed with 1 oz. of cool water, infant formula or other suitable liquids
  • for best results, clean dropper after each use and replace original cap
Age (yr) Weight (lb) Dose
infants under 2 under 24 0.3 mL
children over 2 over 24 0.6 mL
Other Information
  • do not use if printed foil seal under cap is torn or missing
  • store at room temperature
  • do not freeze
  • see bottom panel for lot number and expiration date
Inactive Ingredients

Carbomer 934-P, Citric Acid, Hydroxypropyl Methylcellulose, Natural Flavors, Purified Water, Sodium Benzoate, Sodium Citrate, Sucralose

Description

Drug Facts

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. (1-800-222-1222)

Active Ingredient (in Each 0.3 Ml)

Simethicone 20 mg

Principal Display Panel 30 Ml Bottle Carton

CVS

pharmacy ®

Compare to the

active ingredient in

Infants' MYLICON® Drops*

Infants'

GAS

RELIEF

NON-STAINING FORMULA

SIMETHICONE/ANTIGAS

  • No alcohol
  • No saccharin
  • No artificial flavor

100 Doses

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.

Purpose

Anti-gas

Directions
  • shake well before using
  • all doses 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 be mixed with 1 oz. of cool water, infant formula or other suitable liquids
  • for best results, clean dropper after each use and replace original cap
Age (yr) Weight (lb) Dose
infants under 2 under 24 0.3 mL
children over 2 over 24 0.6 mL
Other Information (Other information)
  • do not use if printed foil seal under cap is torn or missing
  • store at room temperature
  • do not freeze
  • see bottom panel for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

Carbomer 934-P, Citric Acid, Hydroxypropyl Methylcellulose, Natural Flavors, Purified Water, Sodium Benzoate, Sodium Citrate, Sucralose

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. (1-800-222-1222)

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

Simethicone 20 mg

Principal Display Panel 30 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton)

CVS

pharmacy ®

Compare to the

active ingredient in

Infants' MYLICON® Drops*

Infants'

GAS

RELIEF

NON-STAINING FORMULA

SIMETHICONE/ANTIGAS

  • No alcohol
  • No saccharin
  • No artificial flavor

100 Doses

1 FL OZ (30 mL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:43.910366 · Updated: 2026-03-14T22:53:39.434183