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Reboost

Heel Inc

Reboost Nasal Spray


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENTS

Each 20ml contains:

Active Purpose

Ingredients

Argentum nitricum 10X........................Relieves nasal itching

*Euphorbium officinarum 4X…………........Relieves sneezing

Hepar sulphuris calcareum 10X.............Relieves nasal soreness

*Luffa operculata 2X...........................Relieves nasal congestion

 Mercurius iodatus ruber 8X.................Relieves sinus pain

*Mucosa nasalis suis 8X......................Relieves sinus headache

*Pulsatilla 2X.....................................Relieves nasal discharge

*Sinusitisinum 13X.............................Relieves sinus congestion

*Natural Ingredients

INACTIVE INGREDIENTS

Inactive Ingredients: Benzalkonium chloride 0.01%, Disodium phosphate dihydrate, Isotonic sodium chloride solution and Sodium dihydrogen phosphate dihydrate

PURPOSE

Uses

For the temporary relief of minor nasal symptoms:

Nasal Congestion • Sinus Headache and Pressure •

Cold/Flu Nasal Symptoms

REBOOST DOSAGE AND ADMINISTRATION

Standard Dosage: Adults and children 12 years and older: 2 sprays into each nostril every 4 to 6 hours.

Children 4 to 11 years: 1 spray into each nostril every 4 to 6 hours.

For children under 4 years, consult your healthcare provider.

Initial Dosage: Adults and children 12 years and older: 2 sprays into each nostril every 1/2 to 1 hour, until symptoms lessen, then continue with standard dosage. Do not exceed 48 sprays in 24 hours.

Children 4 to 11 years: 1 spray into each nostril every 1/2 to 1 hour until symptoms lessen, then continue with standard dosage. Do not exceed 24 sprays in 24 hours.

For children under 4 years, consult your healthcare provider.

WARNINGS

Warnings

Ask a doctor before use if you have asthma. In rare cases bronchospasm may occur in asthmatic patients. Temporary burning, stinging, sneezing, or increased nasal discharge may occur. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. The use of this dispenser by more than one person may spread infection. If symptoms persist or worsen, a healthcare provider should be consulted. Do not use if known sensitivity to Reboost™ or any of its ingredients exists.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

REBOOST INDICATIONS AND USAGE

For the temporary relief of minor nasal symptoms:

  • Nasal Congestion
  • Sinus Headache and Pressure
  • Cold/Flu Nasal Symptoms

Reboost

Reboost

SILVER NITRATE, EUPHORBIA RESINIFERA RESIN, CALCIUM SULFIDE, LUFFA OPERCULATA FRUIT, MERCURIC IODIDE, SUS SCROFA NASAL MUCOSA, PULSATILLA VULGARIS and SINUSITISINUM SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50114-5423
Route of Administration NASAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SILVER NITRATE SILVER CATION 10 [hp_X]
EUPHORBIA RESINIFERA RESIN EUPHORBIA RESINIFERA RESIN 4 [hp_X]
CALCIUM SULFIDE CALCIUM CATION 10 [hp_X]
LUFFA OPERCULATA FRUIT LUFFA OPERCULATA FRUIT 2 [hp_X]
MERCURIC IODIDE MERCURIC IODIDE 8 [hp_X]
SUS SCROFA NASAL MUCOSA SUS SCROFA NASAL MUCOSA 8 [hp_X]
PULSATILLA VULGARIS PULSATILLA VULGARIS 2 [hp_X]
SINUSITISINUM SINUSITISINUM 13 [hp_X]

Inactive Ingredients

Ingredient Name Strength
benzalkonium chloride
SODIUM CHLORIDE
sodium phosphate, monobasic, dihydrate
sodium phosphate, dibasic, dihydrate

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 20 in 1 BOTTLE, PUMP
2 NDC:50114-5423-9 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2013-02-11


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Be sure to consult your doctor before taking any medication!
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