FDA Label for Nice Assorted Cough Drops
View Indications, Usage & Precautions
Nice Assorted Cough Drops Product Label
The following document was submitted to the FDA by the labeler of this product Leosons. 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 lozenge)
Menthol 5 mg
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 a doctor if
- cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs 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, Ascorbic Acid*, Caramel Color*, D&C Yellow No. 10*, Eucalyptus Oil, FD&C Blue No. 1*, FD&C Red No. 40*, FD&C Yellow No. 6*, Isomalt, Natural and Artificial Flavors, Sodium Citrate*, Tartaric Acid*
*may contain one or more of these ingredients
Otc - Questions
Questions? Call 1-855-452-9500 or email at [email protected]
* Please review the disclaimer below.