Label: REBOOST- antimony potassium tartrate, cupric sulfate, drosera rotundifolia, ipecac, rumex crispus root and spongia officinalis skeleton, roasted syrup
- NDC Code(s): 50114-8550-1
- Packager: Heel Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- ACTIVE INGREDIENTS
Active Ingredients: Each 5ml contains: Antimonium tartaricum 6X, Cuprum sulphuricum 6X, Drosera rotundifolia 4X, Ipecacuanha 4X, Rumex crispus 4X, Spongia tosta 8XClose
- INACTIVE INGREDIENTS
Inactive Ingredients: Purified Water, Honey, Preserved water and Simple syrupClose
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 coughClose
- 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.Close
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.Close
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.Close
- INDICATIONS AND USAGE
For the temporary relief of minor:
- Chest Congestion
- Cough due to colds and flu
- INGREDIENTS AND APPEARANCE
antimony potassium tartrate syrup
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50114-8550 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5) ANTIMONY POTASSIUM TARTRATE 6 [hp_X] in 125 mL CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 6 [hp_X] in 125 mL DROSERA ROTUNDIFOLIA (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA - UNII:QR44N9XPJQ) DROSERA ROTUNDIFOLIA 4 [hp_X] in 125 mL IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC 4 [hp_X] in 125 mL RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT 4 [hp_X] in 125 mL SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED 8 [hp_X] in 125 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HONEY (UNII: Y9H1V576FH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) SUCROSE (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50114-8550-1 1 in 1 CARTON 1 125 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/13/2013 Labeler - Heel Inc (102783016) Establishment Name Address ID/FEI Business Operations Heel Belgium 282761204 manufacture(50114-8550)