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Viburcol

Heel Inc

Viburcol Oral Drops 1 ml vials


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENTS

Active ingredients: Each 1 ml vial contains: Belladonna 6X, Calcarea carbonica 8X, Chamomilla 4X, Dulcamara 6X, Plantago major 4X, Pulsatilla 6X

PURPOSE

Belladonna 6X...................Relieves pain
Calcarea carbonica 8X........Relieves teething pain
Chamomilla 4X..................Relieves irritability during teething
Dulcamara 6X...................Relieves minor aches and pains
Plantago major 4X.............Relieves teething pain
Pulsatilla 6X.....................Relieves pain and restlessness

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

VIBURCOL INDICATIONS AND USAGE

For the temporary relief of minor:

  • Restlessness due to teething
  • Aches and Pains

WARNINGS

If pregnant or breast-feeding, ask a healthcare provider before use. Keep out of reach of children. If symptoms persist or worsen, a healthcare provider should be consulted. Do not use if known sensitivity to Viburcol® or any of its ingredients exists.

VIBURCOL DOSAGE AND ADMINISTRATION

Standard Dosage:

Children 4 to 11 years: 10 drops every 8 hours

For children under 4 years, consult your healthcare provider.

Initial Dosage:

Children 4 to 11 years: 7 drops every 1/2 hour to 1 hour until symptoms lessen, then continue with standard dosage. Do not exceed 84 drops in 24 hours.

For children under 4 years, consult your healthcare provider.

INACTIVE INGREDIENT

Isotonic saline solution

Viburcol

Viburcol

ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, MATRICARIA RECUTITA, SOLANUM DULCAMARA STEM, PLANTAGO MAJOR and PULSATILLA VULGARIS SOLUTION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50114-1434
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ATROPA BELLADONNA ATROPA BELLADONNA 6 [hp_X]
OYSTER SHELL CALCIUM CARBONATE, CRUDE OYSTER SHELL CALCIUM CARBONATE, CRUDE 8 [hp_X]
Matricaria Recutita MATRICARIA RECUTITA 4 [hp_X]
Solanum Dulcamara Top Solanum Dulcamara Top 6 [hp_X]
PLANTAGO MAJOR PLANTAGO MAJOR 4 [hp_X]
PULSATILLA VULGARIS PULSATILLA VULGARIS 6 [hp_X]

Inactive Ingredients

Ingredient Name Strength
SODIUM CHLORIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 VIAL, SINGLE-DOSE
2 NDC:50114-1434-2 10 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2002-09-30


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Be sure to consult your doctor before taking any medication!
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