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Unishield cherry cough - Medication Information

Product NDC Code 49314-0505
Drug Name

Unishield cherry cough

Type Brand
Active Ingredients
Menthol, unspecified form 7.6 mg/1
Route ORAL
Dosage Form LOZENGE
Application Number M012
Labeler Name Unishield
Packages
Package NDC Code Description
49314-0505-5 50 lozenge in 1 box (49314-0505-5)
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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 Antitussive (cough suppressant)/oral anesthetic Questions or comments? 800-480-5855

Spl product data elements

Usually a list of ingredients in a drug product.
Unishield Cherry Cough Menthol EUCALYPTUS OIL MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM CORN SYRUP FD&C RED NO. 40 SUCROSE P

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.
Unishield Cough Drop Cough Suppressant/Oral Anesthetic 50 Drops/Individually Wrapped Cherry Flavored Menthol 7.6 mg Pull To Open • Temporarily relieves sore throat and cough • Pleasant tasting formula • Menthol vapors ease congestion Compare active ingredients to: Hall® Registered Trademark of Warner-Lambert Individually Wrapped Cough Drops 050R

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

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 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.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information 15 calories per drop store at 59º-86ºF (15º-30ºC) protect from moisture & heat

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 feeding
If 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.

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