Otc - Active Ingredient
Hyoscyamus niger 3C HPUS (0.6 mg) (contains less than 10-
9 mg alkaloids)
Nux moschata 4C HPUS (0.6 mg)
Passiflora incarnata 3X HPUS (0.6 mg)
Stramonium 6X HPUS (0.6 mg) (contains less than 10-
8 mg alkaloids)
Sleepcalm Tablet
FDA Label NDC 0220-9310
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Laboratoires Boiron for the product Sleepcalm (NDC 0220-9310). 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, otc - purpose, indications & usage, otc - ask doctor, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Hyoscyamus niger 3C HPUS (0.6 mg) (contains less than 10-9 mg alkaloids) ... Relieves restless sleep associated with nervousness
Nux moschata 4C HPUS (0.6 mg) ... Relieves restless sleep
Passiflora incarnata 3X HPUS (0.6 mg) ... Relieves sleeplessness associated with worries and exhaustion
Stramonium 6X HPUS (0.6 mg) (contains less than 10-8 mg alkaloids) ... Relieves sleeplessness with intermittent awakening
Indications & Usage
Temporarily relieves: occasional sleeplessness, restless sleep, intermittent awakening, helps reduce difficutly falling asleep due to: nervousness, worries
Otc - Ask Doctor
Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks or worsens. Insomnia may be a symptom of a serious underlying illness.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Adults and children 12 years of age and older: Allow 2 tablets to dissolve under the tongue at bedtime.
Children under 12 of age: Ask a doctor.
Other
Do not use if glued carton end flaps are open or if the blister seal is broken.
store below 86 oF (30 oC)
Contains 60 meltaway tablets
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
**C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
No known drug interactions
No artificial colors, flavors or sweeteners
Plant based actives
No daytime grogginess
Inactive Ingredient
Croscarmellose sodium, lactose, magnesium stearate
Otc - Questions
BoironUSA.com
1-800-BOIRON-1 (1-800-264-7661)
Made in France
Distributed by Boiron, Inc.
Newtown Square, PA 19073
* Please review the disclaimer below.
