Reboost
FDA Label NDC 50114-8550

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Heel Inc for the product Reboost (NDC 50114-8550). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, inactive ingredients, purpose, dosage and administration, warnings, keep out of reach of children, indications and usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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:

  • Chest Congestion
  • Cough due to colds and flu

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