Infants GAS DROPS description, usages, side effects, indications, overdosage, supplying and lots more!

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Infants GAS DROPS

Rij Pharmaceutical Corporation

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each 0.3mL)

Simethicone 20 mg

Purpose

Antigas

Infants GAS DROPS Uses

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

Warnings

Keep out of reach of children. In case of overdose get medical help or contact a Poison Control Center right away.

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.of cool water, infant formula or other suitable liquids
  • •for best results, clean dropper after each use and replace original cap.
Age (yrs) Weight (lbs) Dose (ml)
Infants under 2 Under 24 0.3 mL
Children over 2 Over 24 0.6 mL

Other Information

  • TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING
  • •Store at room temperature 15° - 30°C (59 - 86°F)
  • •protect from freezing
  • •each 0.3 mL contains: sodium 1 mg

Inactive ingredients

carbopol - 934-P, citric acid, FD&C red #3, flavor, hypromellose, sodium benzoate, sodium citrate, sodium hypoclorite, sodium saccharin, water

Principal Display Panel

Infants GAS DROPS

Simethicone SUSPENSION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:53807-523
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIMETHICONE 20 mg

Inactive Ingredients

Ingredient Name Strength
SODIUM
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)
CITRIC ACID MONOHYDRATE
FD&C RED NO. 3
HYPROMELLOSES
SODIUM BENZOATE
SODIUM CITRATE
SODIUM HYPOCHLORITE
saccharin sodium
water

Product Characteristics

Color
PINK

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53807-523-30 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part332 1996-03-16


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