Otc - Purpose
Natural relief of anxiousness, nervousness and irritability
Calm Tablet
FDA Label NDC 54973-3331
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 Calm (NDC 54973-3331). 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 - ask doctor, otc - keep out of reach of children, otc - do not use, in case of emergency, 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 |
Calcarea Phosphorica 3X HPUS | restlessness, anxiousness |
Ferrum Phosphoricum 3X HPUS | nervousness |
Kali Phosphoricum 3X HPUS | irritability, anxiousness, nervousness |
Natrum Phosphoricum 3X HPUS | irritability, anxiousness and apprehensiveness |
Magnesia Phosphorica 3X HPUS | anxiousness |
“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Uses
Temporarily relieves the symptoms of restlessness, anxiousness, nervousness, and irritability.
Otc - Pregnancy Or Breast Feeding
As with any drug, ask doctor before use if pregnant or breast-feeding. 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.
Otc - Do Not Use
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 1-2 tablets under tongue 3 times per day. Sudden onset: every 15 minutes for up to 6 doses.
Inactive Ingredient
Acacia Gum, Lactose.
Questions Or Comments?
(800) 624-9659
Principal Display Panel - 50 Tablet Bottle Carton
Non-habit forming
NDC 54973-3331-1
HOMEOPATHIC
SINCE 1903
Hyland's®
Calm
Natural relief of anxiousness,
nervousness and irritability*
50 QUICK-DISSOLVING TABLETS
ACTUAL SIZE 194 MG
* Please review the disclaimer below.
