Otc - Purpose
Natural relief of occasional sleeplessness and restlessness due to stress.
Rest Tablet
FDA Label NDC 54973-3332
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hyland's Inc. for the product Rest (NDC 54973-3332). 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 - purpose, otc - active ingredient, uses, otc - pregnancy or breast feeding, otc - do not use, otc - ask doctor, otc - keep out of reach of children, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredients | Purpose |
Argentum Nitricum 6X HPUS | anxiousness, restlessness, nervousness due to stress |
Causticum 6X HPUS | anxiousness, restlessness, and occasional sleeplessness |
Chamomilla 3X HPUS | occasional sleeplessness |
Cocculus 12X HPUS | wakefulness, anxiousness, restlessness and occasional sleeplessness |
Natrum Muriaticum 12X HPUS | difficulty falling asleep, anxiousness due to stress |
Phosphorus 12X HPUS | occasional sleeplessness, difficulty falling asleep due to stress |
Valeriana 6X HPUS | occasional sleeplessness |
“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Uses
Temporarily relieves the symptoms of occasional sleeplessness, restlessness, irritability, anxiousness, nervousness, wakefulness and difficulty falling to sleep due to stress.
Otc - Pregnancy Or Breast Feeding
As with any drug, ask doctor before use if pregnant or breast-feeding.
Otc - Do Not Use
Do not use • more than directed • if you have a known allergy to any ingredient in this product.
Otc - Ask Doctor
Consult a physician if symptoms persist for more than 7 days or worsen.
Otc - Keep Out Of Reach Of Children
Keep this and all medications out of reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately.
Other Safety Information
Do not use if imprinted tamper band is broken or missing.
In Case Of Emergency
Contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.
Directions
Adults & Children 12 years and over: Dissolve 2-3 tablets under tongue ½ hour to 1 hour before retiring.
Children 6 years to under 12 years of age: Dissolve 1-2 tablets under tongue ½ hour to 1 hour before retiring.
Inactive Ingredient
Acacia Gum, Lactose.
Questions Or Comments?
(800) 624-9659
Principal Display Panel - 50 Tablet Bottle Carton
NDC 54973-3332-1
HOMEOPATHIC
Non-habit forming
SINCE 1903
Hyland's®
Rest
Natural relief of occasional
sleeplessness and restlessness
due to stress*
50 QUICK- DISSOLVING TABLETS
ACTUAL SIZE 194 MG
* Please review the disclaimer below.
