Foster And Thrive Infants Gas Relief 520

Foster And Thrive Infants Gas Relief 520
SPL v2
SPL
SPL Set ID 824c9dff-0a26-4710-a25b-39df631d6fa6
Route
ORAL
Published
Effective Date 2024-12-13
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

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-12

Description

Simethicone 20 mg

Purpose

Antigas


Medication Information

Purpose

Antigas

Description

Simethicone 20 mg

Use(s)

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

Warnings

.

Directions
  • shake well before using
  • all dosages may be repeated as needed, after meals and at bedtime
  • fill enclosed dropper to recommended 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 under 2  under 24 0.3 mL
 children over 2   over 24 0.6 mL


Other Information

store at room temperature

Active Ingredient(s)

Simethicone 20 mg

Inactive Ingradients

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

Questions Or Comments?

Call 833-358-6431 Monday to Friday 9:00 to 7:00 pm EST

Principal Display Panel

NDC 70677-1078-1

COMPARE TO MYLICON® NON-STAINING INFANTS' DROPS 

ACTIVE INGREDIENT* 

Foster and Thrive TM

INFANTS'

Gas Relief  Drops

Simethicone 20 mg

ANTIGAS

Relief of gas symptoms:

  • Pressure
  • Bloating
  • Non-staining Formula
  • Alcohol Free
  • Saccharin Free

1 FL. OZ. (30 mL) 100 Doses

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 right away (1-800-222-1222).


Structured Label Content

Use(s) (USE(S))

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

Purpose (PURPOSE)

Antigas

Warnings (WARNINGS)

.

Directions (DIRECTIONS)
  • shake well before using
  • all dosages may be repeated as needed, after meals and at bedtime
  • fill enclosed dropper to recommended 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 under 2  under 24 0.3 mL
 children over 2   over 24 0.6 mL


Other Information (OTHER INFORMATION)

store at room temperature

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Simethicone 20 mg

Inactive Ingradients (INACTIVE INGRADIENTS)

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

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call 833-358-6431 Monday to Friday 9:00 to 7:00 pm EST

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 70677-1078-1

COMPARE TO MYLICON® NON-STAINING INFANTS' DROPS 

ACTIVE INGREDIENT* 

Foster and Thrive TM

INFANTS'

Gas Relief  Drops

Simethicone 20 mg

ANTIGAS

Relief of gas symptoms:

  • Pressure
  • Bloating
  • Non-staining Formula
  • Alcohol Free
  • Saccharin Free

1 FL. OZ. (30 mL) 100 Doses

When Using This Product (WHEN USING THIS PRODUCT)

do not exceed 12 doses per day

Keep Out of Reach of Children. (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).


Advanced Ingredient Data


Raw Label Data

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