INFANTS GAS RELIEF description, usages, side effects, indications, overdosage, supplying and lots more!

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INFANTS GAS RELIEF

MAJOR Pharmaceuticals Inc.
GCP Laboratories


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 0.3 mL)

Purpose

Antigas

Use


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 inner cheek
  • dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids
  • clean dropper well after each use and replace original cap

Age (years) Weight (lbs) Dose
infants (under 2)
under 24
0.3 mL
children (2 and over)
24 and over
0.6 mL

INFANTS GAS RELIEF Other information

  •  TAMPER-EVIDENT: Do not use if foil seal under cap is broken or missing.
  • store at room temperature
  • do not freeze
  • see bottom panel for lot number and expiration date

Inactive ingredients

carboxymethylcellulose sodium, citric acid, maltitol, microcrystalline cellulose, flavor, purified water, sodium benzoate, sodium citrate, xanthan gum

Questions?

Adverse Drug Event Call: (800)616-2471

package Label

NDC 00904-5894-30

MAJOR

INFANTS' GAS RELIEF DROPS










INFANTS GAS RELIEF

INFANTS GAS RELIEF

Simethicone SUSPENSION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0904-5894
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
MALTITOL
cellulose, microcrystalline
water
SODIUM BENZOATE
ANHYDROUS TRISODIUM CITRATE
XANTHAN GUM

Product Characteristics

Color
white (off-white)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE, DROPPER
2 NDC:0904-5894-30 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part332 2010-12-07


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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