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Drug Facts
Sleep Tablet
FDA Label NDC 54973-3206
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 Sleep (NDC 54973-3206). 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, otc - stop use, otc - pregnancy or breast feeding, 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.
Label Section Quick Index
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| "HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States. | |
| Hyoscyamus Niger 6X HPUS (0.0000001% Alkaloids) | occasional nighttime sleeplessness |
| Ignatia Amara 6X HPUS (0.0000017% Alkaloids) | anxiousness, worry |
| Kali Phosphoricum 3X HPUS | wakefulness, occasional sleeplessness, nervousness |
Uses
Temporarily relieves the symptoms of occasional nighttime sleeplessness and wakefulness due to nervousness, anxiousness, or worry.
Otc - Stop Use
Stop use and ask a doctor if symptoms persist for more than 7 days or worsen.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, 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 immediately.
Directions
Adults and children 12 years and over: Dissolve 2-3 tablets under tongue 1/2 hour to 1 hour before retiring. Children 6 years to under 12 years: Dissolve 1-2 tablets under tongue 1/2 hour to 1 hour before retiring.
Other Information
- do not use if imprinted tamper band is broken or missing
- Hyland's may be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659
Inactive Ingredients
Acacia Gum, Lactose N.F.
Questions Or Comments?
(800) 624-9659
Principal Display Panel - 100 Tablet Bottle Carton
NDC 54973-3206-1
Hyland's®
HOMEOPATHIC
Sleep
Natural Relief of Occasional
Sleeplessness and Nervousness*
100
TABLETS
* Please review the disclaimer below.
