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| Product NDC Code | 54973-3206 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Sleep |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | TABLET | ||||||
| Labeler Name | Hyland's Inc. | ||||||
| Packages |
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Overdosage of Sleep
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.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.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Purpose Hyoscyamus Niger 6X HPUS (0.0000001% Alkaloids, calculated) occasional sleeplessness Ignatia Amara 6X HPUS (0.0000017% Alkaloids, calculated) anxiousness, worry Kali Phosphoricum 3X HPUS wakefulness, occasional sleeplessness, nervousness "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
| occasional sleeplessness | |
| anxiousness, worry | |
| Kali Phosphoricum 3X HPUS | wakefulness, occasional sleeplessness, nervousness |
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Adults and children 12 years and over: Dissolve 2-3 tablets under tongue at bedtime, then 2-3 tablets every 4 hours during the night as necessary. Children 6 years to under 12 years: Dissolve 1-2 tablets under tongue at bedtime, then 1-2 tablets every 4 hours during the night as necessary.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Acacia Gum, Lactose.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses ■ Temporarily relieves symptoms of occasional sleeplessness due to: ■ anxiousness ■ worry ■ wakefulness ■ nervousness
Purpose
Information about the drug product’s indications for use.Relieves Occasional Sleeplessness Due to Nervousness or Worry
Spl product data elements
Usually a list of ingredients in a drug product.Sleep HYOSCYAMUS NIGER, STRYCHNOS IGNATII SEED, and POTASSIUM PHOSPHATE, DIBASIC ACACIA LACTOSE HYOSCYAMUS NIGER HYOSCYAMUS NIGER STRYCHNOS IGNATII SEED STRYCHNOS IGNATII SEED POTASSIUM PHOSPHATE, DIBASIC PHOSPHATE ION
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton HOMEOPATHIC NDC 54973-3206-1 SINCE 1903 Hyland's Sleep* NATURAL ACTIVE INGREDIENTS GENTLE ON YOU Relieves Occasional Sleeplessness Due to Nervousness or Worry 100 QUICK-DISSOLVING TABLETS * SEE NOTE ON SIDE PANEL BELOW DRUG FACTS NATURAL RELIEF Carton
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Indications and Usage Temporarily relieves symptoms of occasional sleeplessness due to: anxiousness worry wakefulness nervousness
Dosage and Administration Adults and children 12 years and over: Dissolve 2-3 tablets under tongue at bedtime, then 2-3 tablets every 4 hours during the night as necessary. Children 6 years to under 12 years: Dissolve 1-2 tablets under tongue at bedtime, then 1-2 tablets every 4 hours during the night as necessary.
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts Active ingredients Purpose Hyoscyamus Niger 6X HPUS (0.0000001% Alkaloids, calculated) occasional sleeplessness Ignatia Amara 6X HPUS (0.0000017% Alkaloids, calculated) anxiousness, worry Kali Phosphoricum 3X HPUS wakefulness, occasional sleeplessness, nervousness "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
Drug Facts (continued) Directions Adults and children 12 years and over: Dissolve 2-3 tablets under tongue at bedtime, then 2-3 tablets every 4 hours during the night as necessary. Children 6 years to under 12 years: Dissolve 1-2 tablets under tongue at bedtime, then 1-2 tablets every 4 hours during the night as necessary.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
| occasional sleeplessness | |
| anxiousness, worry | |
| Kali Phosphoricum 3X HPUS | wakefulness, occasional sleeplessness, nervousness |
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use more than directed.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep this and all medications out of the reach of children.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information ■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? (800) 624-9659
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and consult a physician if symptoms persist for more than 7 days or worsen.
Pregnancy or breast feeding
Pregnancy or Breast feedingAs with any drug, ask a doctor before use if pregnant or breast-feeding.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings As with any drug, ask a doctor before use if pregnant or breast-feeding. Do not use more than directed. Stop use and consult a physician if symptoms persist for more than 7 days or worsen. Keep this and all medications out of the reach of children. 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API