REBOOST- antimony potassium tartrate syrup 
Heel Inc

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

----------

Reboost Cough Syrup

ACTIVE INGREDIENTS

Active Ingredients: Each 5ml contains: Antimonium tartaricum 6X, Cuprum sulphuricum 6X, Drosera rotundifolia 4X, Ipecacuanha 4X, Rumex crispus 4X, Spongia tosta 8X

INACTIVE INGREDIENTS

Inactive Ingredients: Purified Water, Honey, Preserved water and Simple syrup

PURPOSE

Antimonium tartaricum 6X..............Relieves chest congestion

Cuprum sulphuricum 6X.................Relieves cough

Drosera rotundifolia 4X..................Relieves cough

Ipecacuanha 4X.............................Relieves cough

Rumex crispus 4X...........................Relieves cough

Spongia tosta 8X...........................Relieves cough

DOSAGE AND ADMINISTRATION

Standard Dosage: Adults and children 12 years and older: 2 teaspoons every 4 to 6 hours.

Children 4 to 11 tears: 1 teaspoon every 3 to 4 hours.

Children 1 to 4 years, consult your healthcare provider.

Initial Dosage: Adults and children 12 years and older: 2 teaspoons every 1 to 2 hours until symptoms lessen, then continue with standard dosage. Do not exceed 36 teaspoons in 24 hours.

Children 4 to 11 tears: 1 teaspoon every 1 to 2 hours until symptoms lessen, then continue with standard dosage. Do not exceed 18 teaspoons in 24 hours.

Children 1 to 4 years, consult your healthcare provider.

WARNINGS

Do not use in infants younger than 1 year due to the presence of honey. 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 Reboost or any of its ingredients exists.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS AND USAGE

For the temporary relief of minor:

Reboost Cough Syrup.jpg

REBOOST 
antimony potassium tartrate syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50114-8550
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5) ANTIMONY POTASSIUM TARTRATE6 [hp_X]  in 125 mL
CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION6 [hp_X]  in 125 mL
DROSERA ROTUNDIFOLIA (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA - UNII:QR44N9XPJQ) DROSERA ROTUNDIFOLIA4 [hp_X]  in 125 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC4 [hp_X]  in 125 mL
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT4 [hp_X]  in 125 mL
SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED8 [hp_X]  in 125 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HONEY (UNII: Y9H1V576FH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50114-8550-11 in 1 CARTON
1125 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/13/2013
Labeler - Heel Inc (102783016)
Establishment
NameAddressID/FEIBusiness Operations
Heel Belgium282761204manufacture(50114-8550)

Revised: 2/2013
Document Id: ba1d7b8e-0475-40f3-9fef-5b20fb600ec0
Set id: 0ed2766d-df0b-40c9-82e4-aee35cc0332c
Version: 1
Effective Time: 20130213
 
Heel Inc