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

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ShopRite Infants Simethicone

Wakefern Food Corporation

ShopRite Infants’ Simethicone Drops Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 0.3 mL)

Simethicone 20 mg

Purpose

Antigas

ShopRite Infants Simethicone Uses

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

Warnings

When using this product

do not exceed 12 doses per day

Keep out of reach of children.

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 replace 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

store at room temperature (59°-86°F)

Inactive ingredients

citric acid, flavor, hypromellose, maltitol, methylcellulose, mono- and di- glycerides, polyethylene glycol, polyethylene glycol stearate, polysorbate 65, purified water, sodium benzoate, sodium citrate, sorbic acid, xanthan gum

Questions or comments?

1-800-SHOPRITE

Principal Display Panel

Compare to: Active Ingredient in Infants’ Mylicon® Drops

Infants’

SIMETHICONE DROPS

SIMETHICONE 20 mg

ANTI-GAS

Gas Relief

Non-Staining

No Alcohol

No Saccharin

No Artificial Flavor

No Artificial Colors

Dosage Dropper Enclosed

1 FL OZ (30mL)

ShopRite Infants Simethicone

Simethicone EMULSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41190-882
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIMETHICONE 20 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
CITRIC ACID MONOHYDRATE
HYPROMELLOSES
MALTITOL
POLYETHYLENE GLYCOLS
water
SODIUM BENZOATE
SODIUM CITRATE
sorbic acid
XANTHAN GUM
POLYSORBATE 65

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
2 NDC:41190-882-10 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part332 2013-06-16


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Be sure to consult your doctor before taking any medication!
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