FDA Label for Severe Throat Sore Drops
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - ASK DOCTOR
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Severe Throat Sore Drops Product Label
The following document was submitted to the FDA by the labeler of this product Target Corporation Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient in each drop Purposes
Menthol 20mg Cough Suppressant
Oral anesthetic
Otc - Purpose
Temporarily relieves ocassional minor irritation and pain due to:
- sore throat
- sore mouth
Indications & Usage
Temporarily relieves ocassional minor irritation and pain due to:
- sore throat
- sore mouth
Warnings
Warnings
Sore throat warning: severe or persistence sore throat accompanied or followed by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 12 years of age.
Otc - Ask Doctor
Ask a doctor before use if you have
- a severe throat accompanied by difficulty in breathing or that last more than 2 days
- a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting
Otc - Stop Use
Stop use and consult a doctor if
- sore mouth symptons do not improve in 7 days or if irritation, pains or redness persists or worsens.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of the reach of children.
Overdosage
In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- Adults and children 12 years and over: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor.
- Children under 12 years and under do not use
Other Safety Information
- Store in a cool and dry place
Inactive Ingredient
eucalyptus oil, FD&C Blue No.1, glucose syrup, gum arabic, sucrose
Otc - Questions
Questions? or to report and adverse event call: 1-617-848-4560
Monday to Friday 9AM to 4 PM east
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