FDA Label for Sf Menthol Cough Drop
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - ASK DOCTOR
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Sf Menthol Cough Drop Product Label
The following document was submitted to the FDA by the labeler of this product United Natural Foods, Inc. Dba Unfi. 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)
Menthol 5.8mg
Otc - Purpose
Purposes
Cough suppressant
Oral anesthetic
Indications & Usage
Uses temporarily relieves:
- cough as may occur with a cold or inhaled irritants
- occasional minor irritation and sore throat
Warnings
Warnings
sore throat warning: if sore throat is severe,
persists for more than 2 days, is accompanied or
followed by fever, headaches, rash, swelling, nausea,
or vomiting, consult a doctor promptly. These
symptoms may be serious.
Otc - Ask Doctor
Ask a doctor before use if you have
- persistent or chronic cough such as occurs with smoking,
- cough accompanied by excessive phegm (mucus)
asthma, or emphysema
Otc - When Using
When using this product
- do not exceed recommended dosage
Otc - Stop Use
Stop use and consult doctor if
- cough persists for more than 7 days, tends to recur, or is
- sore throat is severe, or irritation, pain or redness lasts or
- sore mouth does not improve in 7 days
accompanied by fever, rash, or persistent headache.
These could be signs of a serious condition.
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
Dosage & Administration
Directions
Adults and children 5 years and over:
allow 1 drop to dissolve
slowly in mouth. May be
repeated every two hours
as necessary or as
directed by a doctor.
Children under 5 years:
ask a doctor
Other Safety Information
Other information
- 6 calories per drop
Inactive Ingredient
Inactive Ingredients: Acesulfame potassium, blue
flakes (FD&C blue no 1, glycerin, gum arabic, potassium
sorbate), eucalyptus oil, FD&C red no 40, hydrogenated
starch hydrosate, isomalt, natural & artificial flavoring,
sucralose and water. soybean oil and corn starch used as
processing aids.
Otc - Questions
Questions? Or to report an adverse event
call 1-877-932-7948
* Please review the disclaimer below.