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| Product NDC Code | 54973-9147 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Motion sickness |
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| Type | Brand | ||||||||
| Pharm Class | Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS] |
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| Active Ingredients |
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| Route | ORAL | ||||||||
| Dosage Form | TABLET, SOLUBLE | ||||||||
| Labeler Name | Hyland's Consumer Health Inc. | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Purpose Cocculus Indicus 30X HPUS nausea, dizziness, vomiting Nux Vomica 6X HPUS (0.0000016% Alkaloids, calculated) sour stomach, nausea Petroleum 12X HPUS nausea, dizziness Tabacum 6X HPUS headache with nausea, vomiting "HPUS" is the Homeopathic Pharmacopoeia of the United States.
| Cocculus Indicus 30X HPUS | nausea, dizziness, vomiting |
| sour stomach, nausea | |
| Petroleum 12X HPUS | nausea, dizziness |
| Tabacum 6X HPUS | headache with nausea, vomiting |
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 ■ Use as directed. Adults and children 12 years and over At onset of symptoms, dissolve 2 tablets under tongue every 4 hours until relieved, up to 6 times per day. Children 6 years to under 12 years At onset of symptoms, dissolve 1 tablet under tongue every 4 hours until relieved, up to 6 times per day.
| Adults and children 12 years and over | At onset of symptoms, dissolve 2 tablets under tongue every 4 hours until relieved, up to 6 times per day. |
| Children 6 years to under 12 years | At onset of symptoms, dissolve 1 tablet under tongue every 4 hours until relieved, up to 6 times per day. |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredient 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 associated with motion sickness, including: ■ nausea ■ headache with nausea ■ vomiting ■ dizziness ■ sour stomach
Purpose
Information about the drug product’s indications for use.Temporarily relieves symptoms associated with motion sickness, including nausea, headache with nausea, vomiting, dizziness, sour stomach
Spl product data elements
Usually a list of ingredients in a drug product.Motion Sickness strychnos nux-vomica seed, tobacco leaf, kerosene, and anamirta cocculus seed LACTOSE STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED TOBACCO LEAF TOBACCO LEAF KEROSENE KEROSENE ANAMIRTA COCCULUS SEED ANAMIRTA COCCULUS SEED
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 Hyland's NATURALS™ MOTION SICKNESS* NON-DROWSY • NAUSEA • VOMITING • DIZZINESS 50 QUICK-DISSOLVING TABLETS HOMEOPATHIC 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 associated with motion sickness, including: nausea headache with nausea vomiting dizziness sour stomach
Dosage and Administration Directions ■ Use as directed. Adults and children 12 years and over At onset of symptoms, dissolve 2 tablets under tongue every 4 hours until relieved, up to 6 times per day. Children 6 years to under 12 years At onset of symptoms, dissolve 1 tablet under tongue every 4 hours until relieved, up to 6 times per day.
| Adults and children 12 years and over | At onset of symptoms, dissolve 2 tablets under tongue every 4 hours until relieved, up to 6 times per day. |
| Children 6 years to under 12 years | At onset of symptoms, dissolve 1 tablet under tongue every 4 hours until relieved, up to 6 times per day. |
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 Cocculus Indicus 30X HPUS nausea, dizziness, vomiting Nux Vomica 6X HPUS (0.0000016% Alkaloids, calculated) sour stomach, nausea Petroleum 12X HPUS nausea, dizziness Tabacum 6X HPUS headache with nausea, vomiting "HPUS" is the Homeopathic Pharmacopoeia of the United States.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
| Cocculus Indicus 30X HPUS | nausea, dizziness, vomiting |
| sour stomach, nausea | |
| Petroleum 12X HPUS | nausea, dizziness |
| Tabacum 6X HPUS | headache with nausea, vomiting |
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 out of reach of children.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.DO NOT USE IF TAMPER-EVIDENT SEAL 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? www.hylands.com or [email protected]
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 ask a doctor if symptoms persist more than 72 hours or worsen.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding Ask a health professional before use.
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 Stop use and ask a doctor if symptoms persist more than 72 hours or worsen. If pregnant or breastfeeding Ask a health professional before use. Keep out of reach of children.
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