FDA Label for Menthol Cough 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
Menthol Cough Drops Product Label
The following document was submitted to the FDA by the labeler of this product Boston Nutraceutical Production, S.l. 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 5.4 mg
Cough Suppressant
Oral Anesthetic
Otc - Purpose
Purposes
Temporarily relieves ocassional minor irritation and pain due to:
- sore throat
- sore mouth
Indications & Usage
Purposes
Temporarily relieves ocassional minor irritation and pain due to:
- sore throat
- sore mouth
Warnings
Warnings
Sore throat warning: severe or persistant sore throat accompanied by high fever headache, nausea and vomiting maybe serious Consult a doctor promptly. Do not use more than 2 days or administer to children under 12 years old.
Otc - Ask Doctor
Ask a doctor before use if you have:
- a severe throat accompanied by difficulty in breathing or that lasts more than 2 days
- a sore throat accompanied by fever, headache, rash, swelling, nausea and vomiting
Otc - Stop Use
Stop use and consult doctor if
- sore mouth symptons does not improve in 7 days or if,
- irritation, pain 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 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. Repeat every two hours as needed or as directed by a doctor.
- Children under 12 years do not use
Other Safety Information
Other information
- Store in a cool and dry place
- 11 calories per drop
Inactive Ingredient
glucose, syrup, sucrose
Otc - Questions
Questions or to report an adverse event call:
1 833 5521737
Package Label.Principal Display Panel
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