Gas-aid Drops For Infant's

Gas-aid Drops For Infant's
SPL v15
SPL
SPL Set ID 06665701-5f1c-4f8f-8775-e0a4a9ef2029
Route
ORAL
Published
Effective Date 2016-01-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (20 mg)
Inactive Ingredients
Benzoic Acid Magnesium Aluminum Silicate Water Sorbitol Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-08-08

Description

simethicone 20 mg

Purpose

Antigas


Medication Information

Purpose

Antigas

Description

simethicone 20 mg

Uses

relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods

Directions
  • shake well before using
  • all dosages may be repeated as needed, after meals and at bedtime
  • fill enclosed dropper to recommend dosage level
  • dispense liquid slowly into baby's mouth, toward the inner cheek
  • may mix with 1 oz. of cool water, infant formula or other suitable liquids
  • clean dropper after each use and close the bottle to maintain child resistance
 age (yr)                                  weight (lb)                             dose
 infants under2  under 24  0.3 mL
 children over 2  over 24

 0.6 mL                                                               

Other Information

store at room temperature

Inactive Ingredients

benzoic acid, flavor, magnesium aluminum silicate, purified water, simethicone emulsion, sorbitol, xanthan gum

Principal Display Panel

Gas-Aid drops for infant's

Fast relief of

Simethicone Anti-Gas

No Saccharin or artificial flavor

Alcohol and dye Free

Non-staining

1 fl oz (30 mL)

When Using This Product

do not exceed 12 doses per day

Keep out of reach of children. In case of overdose get medical help or contact a poison control center immediately.

Active Ingredient (in Each 0.3 Ml)

simethicone 20 mg


Structured Label Content

Uses

relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods

Purpose

Antigas

Directions
  • shake well before using
  • all dosages may be repeated as needed, after meals and at bedtime
  • fill enclosed dropper to recommend dosage level
  • dispense liquid slowly into baby's mouth, toward the inner cheek
  • may mix with 1 oz. of cool water, infant formula or other suitable liquids
  • clean dropper after each use and close the bottle to maintain child resistance
 age (yr)                                  weight (lb)                             dose
 infants under2  under 24  0.3 mL
 children over 2  over 24

 0.6 mL                                                               

Other Information (Other information)

store at room temperature

Inactive Ingredients (Inactive ingredients)

benzoic acid, flavor, magnesium aluminum silicate, purified water, simethicone emulsion, sorbitol, xanthan gum

Principal Display Panel

Gas-Aid drops for infant's

Fast relief of

Simethicone Anti-Gas

No Saccharin or artificial flavor

Alcohol and dye Free

Non-staining

1 fl oz (30 mL)

When Using This Product (When using this product)

do not exceed 12 doses per day

Keep out of reach of children. In case of overdose get medical help or contact a poison control center immediately.

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

simethicone 20 mg


Advanced Ingredient Data


Raw Label Data

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