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| Product NDC Code | 83698-620 | ||||
|---|---|---|---|---|---|
| Drug Name | Quality choice cough drops vanilla honey |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LOZENGE | ||||
| RxCUI drug identifier | 616344 | ||||
| Application Number | M012 | ||||
| Labeler Name | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | ||||
| 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 ingredient (per drop) Menthol 2.5 mg
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 5 years and over: dissolve 2 drops (one at a time) slowly in the mouth. Repeat every 2 hours as needed • children under 5 years: ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients beta carotene, flavors, glucose syrup, honey, soy lecithin, sucrose, 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 temporary relieves: • cough due to cold • occasional minor irritation or sore throat
Purpose
Information about the drug product’s indications for use.Purposes cough suppressant, oral anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.QUALITY CHOICE Cough Drops Vanilla Honey Cough Drops Vanilla Honey BETA CAROTENE CORN SYRUP HONEY SOYBEAN LECITHIN SUCROSE WATER MENTHOL, UNSPECIFIED FORM MENTHOL Amber
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.Packaging Vanilla Honey
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
RESEALABLE BAG Compare to Active Ingredient of Halls® Relieves Coughs & Soothes Sore Throats Soothing Drops, Starts Working In Seconds Temporarily Relieves Cough CLOSE BAG TO MAINTAIN FRESHNESS CHOKING WARNING: NOT FOR CHILDREN UNDER 4. QC 100% SATISFACTION GUARANTEED ® Distributed by CDMA, Inc. Novi, MI 48375 www.qualitychoice.com Questions: 800-935-2362 Made In China
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? Call 800 935 2362 Monday-Friday 9AM-5PM EST
Storage and handling
Information about safe storage and handling of the drug product.Other information • 10 calories per drop • contains: SOY.
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 Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or follow headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These may be serious. Ask a doctor before use if you have: • persistent or chronic cough such as occurs with smoking, asthma, or emphysema • cough accompanied by excessive phlegm (mucus). Stop use and ask a doctor if: • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. • sore mouth does not improve in 7 days • irritation, pain, or redness persists or worsens. 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