Leader Infants Gas Relief description, usages, side effects, indications, overdosage, supplying and lots more!

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Leader Infants Gas Relief

Cardinal Health

Leader Infants Gas Relief Drops


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 0.3 mL)

Simethicone 20 mg

Purpose

Antigas

Leader Infants Gas Relief Uses

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

Warnings

Keep out of reach of children.

Directions

  • shake well before using
  • all dosages 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 also be mixed with 1 oz. cool water, infant formula or other suitable liquids
  • clean dropper after each use - replace bottle with 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 in printed seal under cap is torn or missing
  • store at room temperature
  • do not freeze
  • see bottom panel for lot and expiration date

Inactive ingredients

carboxymethylcellulose sodium, citric acid, microcrystalline cellulose, natural flavors, PEG-40 monostearate, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol.

Principal Display Panel

Compare to Infants' Mylicon Drops active ingredient

Infants' Gas Relief Drops

Anti-gas/Simethicone

Non-Staining

suitable for infant use

no artificial colors

no saccharin

alcohol free

1 Fl. OZ (30ml)

Leader Infants Gas Relief

Leader Infants Gas Relief

Simethicone EMULSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37205-119
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIMETHICONE 20 mg

Inactive Ingredients

Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM
ANHYDROUS CITRIC ACID
cellulose, microcrystalline
PEG-40 STEARATE
POTASSIUM SORBATE
water
SODIUM BENZOATE
SORBITAN MONOSTEARATE
sorbitol

Product Characteristics

Color
WHITE (white to off white, opaque)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE, DROPPER
2 NDC:37205-119-10 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part332 2010-03-08


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Be sure to consult your doctor before taking any medication!
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