FDA Label for Sleepcalm
View Indications, Usage & Precautions
Sleepcalm Product Label
The following document was submitted to the FDA by the labeler of this product Laboratoires Boiron. 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.
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)
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.