Menthol Cough Drops
Menthol 5 mg Purpose: Cough suppressant.
Menthol Cough Drops
FDA Label NDC 72432-200
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by La Tia Trini Sa De Cv for the product Menthol Cough Drops (NDC 72432-200). 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 menthol cough drops, purpose, uses, warnings, ask a doctor before use if you have:, when using this product, stop use and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Cough suppressant
Uses
Temporarily relieves:
- Cough as may occur with a cold or inhaled irritants.
- Ocasional minor irritation and sore throat.
Warnings
Sore throat warning if sore throat is severe, persists, for more than 2 days, is accompained or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. This symptoms may be serious.
Ask A Doctor Before Use If You Have:
• Persistent or chronic cough such as occurs with smoking, asthma, or emphysema. • Cough accompained by excessive phlegm (mocus).
When Using This Product
Do not exceed recommended dosage.
Stop Use And Ask A Doctor If
Cough persists for more than 7 days, tends to recur, or is accompained by fever, rash, or persisstent headache. This could be signs of a serious condition.
Sore throat is severe, or irritation, pain or redness lasts or worsens.
If pregmant or breast-feeding Ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- Adults and children 6 years and older: Disolve 1 drop slowly in the mouth. May be repeated every hour as needed.
- Children under 6 years: Use only under adult supervision.
Other Information
Contains: Soy
Inactive Ingredients
Anhydrous dextrose, citric acid monohydrate, cordia boissieri whole, eucalyptus globulus leaf, FD&C Blue No.1, honey, mint, myrrh, propolis wax, sambucus nigra flower, soy lecithin, sucrose, verbascum densiflorum flower. Contains FD&C Yellow No. 5 (tartrazine) as a color additive.
Package Label - Menthol Drops
MentholDrops NDC 72432-200-01
Mentholdrops (Mentholdrops)
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