Simethicone description, usages, side effects, indications, overdosage, supplying and lots more!

Simethicone

Physicians Total Care, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Infants Simethicone Drops

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Simethicone 20 mg

Anti-gas

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

In case of overdose, get medical help or contact a Poison Control Center right away.

  • 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 of cool water, infant formula or other suitable liquids
  • for best results, clean dropper after each use and replace original cap
Age Weight Dose
newborn  - - - - 0.3 mL
infants under 2 years under 24 lbs 0.3 mL
children over 2 years over 24 lbs 0.6 mL
  • store at room temperature 15°- 30°C (59°- 86°F)
  • do not freeze

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

carbomer, citric acid, FD&C  red #3, flavor, hypromellose, purified water, saccharin sodium, sodium benzoate, sodium citrate

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 6/10  R6
8276455  0894



Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Simethicone

Simethicone SOLUTION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54868-5620(NDC:0603-0894)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIMETHICONE 63.3 mg
SILICON DIOXIDE 3.7 mg

Inactive Ingredients

Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE B
ANHYDROUS CITRIC ACID
FD&C RED NO. 3
HYPROMELLOSES
water
saccharin sodium
SODIUM BENZOATE
SODIUM CITRATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE
2 NDC:54868-5620-0 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part332 2007-10-30


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Be sure to consult your doctor before taking any medication!
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