Jet Lag Relief
FDA Label NDC 47242-0041

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Homeostasis Laboratories, Inc. for the product Jet Lag Relief (NDC 47242-0041). 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 otc - active ingredient, uses, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active IngredientsPurpose
Aconitum napellus 30C, HPUSRelieves anxiety
Argentum nitricum 30C, HPUSRelieves anticipation anxiety
Arnica montana 30C, HPUSRelieves weakness and exhaustion
Arsenicum album 30C, HPUSRelieves restlessness
Coffea cruda 30C, HPUSRelieves drowsiness
Gelsemium 30C, HPUSRelieves anxiety
Nux vomica 30C, HPUSRelieves heartburn
Tabacum 30C, HPUSRelieves nausea from motion

"HPUS" indicates that the ingredient is officially included in the Homeopathic Pharmacopeia of the United States and the manufacturer has followed all guidelines set forth.

Statement of Identity: Stimulant.

Uses

For the relief of the symptoms of jet lag, including weakness, fatigue, nausea and exhaustion caused by lengthy flights or disruptions of normal sleep patterns.

Warnings

  • Do not use if outer package seal is broken.
  • Stop use and consult a doctor if symptoms do not improve within 3 days or are accompanied by a fever.
  • Not intended as a substitute for sleep.
  • Consult a doctor before use in children younger than 8 years of age.

Otc - Pregnancy Or Breast Feeding

  • If pregnant or breast-feeding, consult a health professional before use.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.

Directions

(adults and children 8 years of age and older)

Chew two tablets thoroughly at take-off, allowing each to dissolve in the mouth, then swallow. Then take two every two hours, and one after landing. However, intervals of up to fours hours between tablets are acceptable if sleeping.

Other Information

  • Safe to take with all other medications.
  • Store at 68-77°F (20-25°C) and keep out of direct sunlight.
  • Avoid humid or damp storage conditions. Close well when not in use.

Inactive Ingredients

Lactose, magnesium stearate (vegetable source), stevia leaf extract.

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