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| Product NDC Code | 47682-018 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Green guard cough drop relief |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | LOZENGE | ||||||
| Application Number | M012 | ||||||
| Labeler Name | Unifirst First Aid Corporation | ||||||
| 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 (in each drop) Menthol 7.6 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 do not use more than directed Adults and children: (12 years and older) Allow 1 drop to dissolve slowly in the mouth. May be repeated every 2 hours as necessary or as directed by a doctor. Children under 12 years: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients cherry flavor, corn syrup, eucalyptus oil, FD&C red #40, sucrose
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 cough as may occur with a cold or inhaled irritants occasional minor irritation and sore throat
Purpose
Information about the drug product’s indications for use.Purpose Anititussive (cough suppressant)/oral anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Green Guard Cough Drop Relief Menthol EUCALYPTUS OIL FD&C RED NO. 40 SUCROSE MENTHOL MENTHOL CORN SYRUP red OVAL P Cherry
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.Green Guard Cough Drop Label Green Guard Cough Drop Relief Label Medicated Cherry Cough Drop relief Green Guard ® Pull To Open Tire Para Abrir Menthol 7.6mg Mentol 7.6mg Cough Supressant/Anethetic Suprime la tos/anestesico 125 Drops Order #2242 Distributed by Green Guard®, St Louis, MO 63045 GG Cherry
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 15 calories per drop store at 59º-86ºF (15º-30ºC) protect from moisture & heat
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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)
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 drugs out of the 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 or comments? 1-800-869-6970
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 ■ 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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, 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 Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. These symptoms 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 If pregnant or breast-feeding, ask a health professional before use. Keep this and all drugs out of the 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