FDA Label for Natural Herbal 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
Natural Herbal 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 4.8 mg
Cough Suppressant
Oral Anesthetic
Otc - Purpose
Purposes
Temporarily relieves :
- cough as may occur with a cold
- occasional minor irritation and sore throat
Indications & Usage
Purposes
Temporarily relieves :
- cough as may occur with a cold
- occasional minor irritation and sore throat
Warnings
Warnings
Sore throat warning: is sore throat is severe, persist for more than 2 days, is accompanied or followed by fever headache, rash, swelling, nausea and vomiting maybe serious consult a doctor promptly. If sore mouth symptons do not improve in 7 days, see your dentist or doctor promptly. These symptons may be serious
Otc - Ask Doctor
Ask a doctor before use if you have
- Persistent or chronic cough such as occurs with smoking, asthma or ephysema.
- Cough accompanied by excessive pleghm (mucus)
Otc - Stop Use
Stop use and consult doctor if
- cough persist for more than 7 days or tends to recur or is accompanied by fever, rash or persistent headache. These could be signs of a serious conditions
- sore throat is severe or irritation, pain or redness lasts or worsens.
- sore mouth does not improve in 7 days
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 6 years and over: allow 2 drops to dissolve slowly in mouth one at a time. Maybe repeated every two hours as needed or as directed by a doctor.
- Children under 6 years ask a doctor
Other Safety Information
Other information
- Store in a cool and dry place
- 11 calories per drop
Inactive Ingredient
corn syrup, sucrose, caramel color, elderflower, honehound, hyssop, lemon balm, liden fiwer, malow, peppermint, sage, thyme, wild thyme, natural flavours
Otc - Questions
Questions or to report an adverse event call:
1 617-848-4560
Monday to Friday: 9:00 am to 4:00 pm ET
Package Label.Principal Display Panel
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