Infant's Gas Relief

Infant's Gas Relief
SPL v1
SPL
SPL Set ID d91c8fa1-9036-4c80-9b15-65100a3a7be3
Route
ORAL
Published
Effective Date 2012-06-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone 410 (20 mg)
Inactive Ingredients
Sodium Benzoate Citric Acid Monohydrate Hypromelloses Sucralose Vanillin Sodium Citrate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-02-03
Description

Drug Facts

Purpose

Anti-gas

Medication Information

Purpose

Anti-gas

Description

Drug Facts

Uses

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

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.

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

Active Ingredient (in Each 0.3 Ml)

Simethicone 20 mg

Principal Display Panel 15 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

50 Doses

0.5 FL OZ (15 mL)

Structured Label Content

Uses

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

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.

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

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

Simethicone 20 mg

Principal Display Panel 15 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 15 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

50 Doses

0.5 FL OZ (15 mL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:29.190321 · Updated: 2026-03-14T22:53:10.919261