The following Structured Product Label (SPL) was submitted to the FDA by Hyland's Inc. for the product Calms Forte (NDC 54973-3257). 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 other, otc - purpose, uses, warnings, otc - ask doctor, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
In case of emergency or accidental overdose, 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.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE,
NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
| Active ingredients | Purpose |
|---|---|
| "HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States. | |
| Avena Sativa 4X HPUS | stress, nervousness |
| Calcarea Phosphorica 3X HPUS | restlessness |
| Chamomilla 4X HPUS | nervous irritability |
| Ferrum Phosphoricum 3X HPUS | nervousness |
| Humulus Lupulus 4X HPUS | occasional sleeplessness |
| Kali Phosphoricum 3X HPUS | irritability |
| Magnesia Phosphorica 3X HPUS | mental anxiousness |
| Natrum Phosphoricum 3X HPUS | anxiousness |
| Passiflora 4X HPUS | restless sleep from exhaustion |
Temporarily relieves the symptoms of occasional sleeplessness or restlessness with accompanying stress, anxiousness, nervousness and irritability.
occasional sleeplessness or restlessness with accompanying stress, anxiousness, nervousness and irritability. Changed "and" to "or"
As with any drug, ask a doctor before use if pregnant or breast-feeding.
Consult a physician if symptoms persist for more than 7 days or worsen.
Keep this and all medications out of the reach of children.
Adults and children 12 years and over | As a relaxant: swallow 1-2 tablets with water until relieved, up to 3 times per day. For occasional sleeplessness: 1-3 tablets before bedtime. |
Children 6 years to under 12 years | As a relaxant: swallow 1 tablet with water until relieved, up to 3 times per day. For occasional sleeplessness: 1-2 tablets before bedtime. |
Lactose, Magnesium Stearate, Microcrystalline Cellulose, Starch (Corn and Tapioca).
(800) 624-9659
Dosage and Administration
Adults and children 12 years and over | As a relaxant: swallow 1-2 tablets with water until relieved, up to 3 times per day. For occasional sleeplessness: 1-3 tablets before bedtime. |
Children 6 years to under 12 years | As a relaxant: swallow 1 tablet with water until relieved, up to 3 times per day. For occasional sleeplessness: 1-2 tablets before bedtime. |
NDC 54973-3257-1
HOMEOPATHIC
NON-HABIT
FORMING
Natural
Relief
SINCE 1903
Hyland's
Calms Forté
®
Sleep Aid
Relieves stress to help you sleep*
Relief of:
Occasional Sleeplessness
Restless Sleep
Stress
50 Tablets| Actual Size 259 mg
*SEE NOTE ON BACK PANEL BELOW DRUG FACTS
* Please review the disclaimer below.
