FDA Label for Calms Forte
View Indications, Usage & Precautions
Calms Forte Product Label
The following document was submitted to the FDA by the labeler of this product Hyland's Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
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.
Otc - Purpose
| 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 |
Uses
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"
Warnings
As with any drug, ask a doctor before use if pregnant or breast-feeding.
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 the reach of children.
Directions
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. |
Other Information
- Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.
Inactive Ingredients
Lactose, Magnesium Stearate, Microcrystalline Cellulose, Starch (Corn and Tapioca).
Questions Or Comments?
(800) 624-9659
Recent Major Changes
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. |
Principal Display Panel - 50 Tablet Bottle Carton
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.