Otc - Active Ingredient
Active ingredient (in each lozenge)
Menthol 5 mg
Nice Citrus Cough Drops Lozenge
FDA Label NDC 69626-0044
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Leosons Overseas Corp for the product Nice Citrus Cough Drops (NDC 69626-0044). 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 - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, 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 suppresses / relieves:
- coughs due to minor throat and bronchial irritation from a cold or inhaled irritants
- occasional minor sore throat pain
Warnings
Warnings
Ask a doctor before use if you have
- chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
Otc - When Using
When using this product
- do not use more than directed, taking more may have a laxative effect
Otc - Stop Use
Stop use and ask doctor if
- cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signes of a serious condition.
- sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, swelling, nausea or vomiting
- sore mouth symptoms last more than 7 days, or irritation, pain or redness continues or worsens
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Directions
- dissolve a lozenge slowly in mouth
- may be repeated every hour for coughs as needed or as directed by a doctor
- may be repeated every 2 hours for sore throat
- do not take more than 10 lozenges per day
adults and children 6 years and older - 5 mg
children under 6 years - ask a doctor
Inactive Ingredient
Inactive Ingredients
Acesulfame Potassium, Citric Acid, D&C Yellow No. 10, Eucalyptus Oil, Isomalt, Lemon Oil, Other Natural and Artificial Flavors, Sodium Citrate
Otc - Questions
Questions? Call 1-855-452-9500 or email at [email protected]
* Please review the disclaimer below.
