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Product NDC Code | 80771-001 | ||||
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Drug Name | Wild horse 777 oral |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 2398340 | ||||
Application Number | M022 | ||||
Labeler Name | Wild Horse 777, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient: Phenol 0.6% Purpose: Anesthetic/Analgesic
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 - 12 years old - adult:3 sprays. - 6-12 years old: 2 sprays. - 3-6 years old: 1 spray. - Children under age 3:1 spray. Consult a physician. - User should be in an upright position. - To use, remove cap, depress the pump completely to spray directly into mouth and throat. - Each spray is followed by a small sip of lukewarm water (<100 °F). - Swish water thoroughly for a few seconds, then swallow. - Day 1: every 3-4 hours. - Day 2: every 3-4 hours. - Day 3: twice a day. - Day 4: at bedtime. - Day 5: at bedtime. - Day 6-9: skip. - Day 10: at bedtime (final dose).
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredient: Purified mineral water
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 sore throate pain and minor mouth irritation.
Purpose
Information about the drug product’s indications for use.Purpose: Anesthetic/Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Wild Horse 777 Oral PHENOL WATER PHENOL PHENOL
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.Package Labeling: 1
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
Other Information - Store and use at room temperature. - Inspect the bottle for integrity. - Do not use if the safety seal is torn or broken.
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions and Comments: 1-800-880-1993 www.wildhorse777.net
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 you experience any discomfort while using this product. - In case of overdose, get medical help or contact a Poison Control Center at 1-800-222-1222 right away.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, consult a health care 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 - Use only as directed. - The use of this container by more than one person may spread infection. If pregnant or breastfeeding, consult a health care professional before use. Keep out of reach of children. Stop use and ask a doctor - if you experience any discomfort while using this product. - In case of overdose, get medical help or contact a Poison Control Center at 1-800-222-1222 right away.
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