Infant's Gas Relief

Infant's Gas Relief
SPL v1
SPL
SPL Set ID 7b44851a-9fe4-4e5d-922b-89fe84d301ca
Route
ORAL
Published
Effective Date 2013-12-03
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 2013-04-15

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.

(1-800-222-1222)

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
  • only use the enclosed syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
  • remove cap and insert syringe into hole at top of bottle and turn upside down. Pull back plunger of syringe until syringe filled slightly over prescribed level. Turn to original position, simply push plunger back until you have reached the prescribe level. Pull syringe out of the bottle 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 syringe 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 the neck wrap imprinted with "Safety Seal" is broken 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

Questions Or Comments?

1-800-Walgreens (1-800-925-4733)

Active Ingredient (in Each 0.3 Ml)

Simethicone 20 mg

Principal Display Panel 30 Ml Bottle Carton

Well at

Walgreens

WALGREENS PHARMACIST RECOMMENDED

Infants'

Gas Relief

Simethicone 20 mg/Dose

Anti-Gas

  • Nonstaining formula
  • No alcohol
  • No saccharin
  • No artificial flavor
  • New dosing syringe design

100 DOSES

Compare to Infants' Mylicon®

Drops active ingredient‡‡

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.

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)

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
  • only use the enclosed syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
  • remove cap and insert syringe into hole at top of bottle and turn upside down. Pull back plunger of syringe until syringe filled slightly over prescribed level. Turn to original position, simply push plunger back until you have reached the prescribe level. Pull syringe out of the bottle 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 syringe 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 the neck wrap imprinted with "Safety Seal" is broken 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

Questions Or Comments? (Questions or comments?)

1-800-Walgreens (1-800-925-4733)

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)

Well at

Walgreens

WALGREENS PHARMACIST RECOMMENDED

Infants'

Gas Relief

Simethicone 20 mg/Dose

Anti-Gas

  • Nonstaining formula
  • No alcohol
  • No saccharin
  • No artificial flavor
  • New dosing syringe design

100 DOSES

Compare to Infants' Mylicon®

Drops active ingredient‡‡

1 FL OZ (30 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)