Otc - Active Ingredient
Active ingredient (in each drop)
Menthol 7.6 mg
Heb Sf Honey Lemon Cough Drops Lozenge
FDA Label NDC 37808-483
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Heb for the product Heb Sf Honey Lemon Cough Drops (NDC 37808-483). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Cough suppressant / Oral anesthetic
Indications & Usage
Uses temporarily relieves:
- cough as may occur with a cold
- occasional minor irritation and sore throat
Warnings
Warnings
Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompamied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or 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, asthma, or emphysema
- cough accompanied by excessive phlegm (mucus)
Otc - Stop Use
Stop use and consult doctor if
- cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
- 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 pregant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of 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
- Excess consumption may cause a laxative effect.
- do not use if bag is torn or open
Inactive Ingredient
Inactive ingredients: Acesulfame potassium, beta carotene, corn starch, eucalyptus oil, glycerin, isomalt, maltitol syrup, medium chain triglycerides, natural and artificial flavors, soybean oil, sucralose and water.
Otc - Questions
Questions? Or to report an adverse event call 1-800-245-2898. Monday through Friday, 9AM to 4PM EST
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