Other
Cough Drops
Cough Drops
FDA Label NDC 80404-501
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Xinsanyang Pharmaceutical (xiamen) Co., Ltd. for the product Cough Drops (NDC 80404-501). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Menthol
Otc - Purpose
cough suppressant, oral anesthetic
Indications & Usage
temporarily relieves: cough due to cold, occasional minor irritation or sore throat
Warnings
Sore throat warning: lf sore throat is severe, persists for more than 2 days, isaccompanied or follow headache, rash, swelling, nausea, or vomiting, consult a doctorprompfly. These may be serious.
Otc - Do Not Use
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).
Stop use and ask a doctor if: cough persists for more than 1 week, tends to recur,
or is accompained by fever, rash, or persistent headache. These could be signs of a
serious condition. sore mouth does not improve in 7 days
irritation, pain, or redness persists or worsens.
Otc - When Using
adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeatevery 2 hours as needed.
children under 5 years: ask a doctor.
Otc - Stop Use
Stop use and ask a doctor if: cough persists for more than 1 week, tends to recur,
or is accompained by fever, rash, or persistent headache. These could be signs of a
serious condition. sore mouth does not improve in 7 days irritation, pain, or redness
persists or worsens.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeatevery 2 hours as needed.
children under 5 years: ask a doctor.
Storage And Handling
Dry, avoid sunlight
Inactive Ingredient
EUCALYPTUS OIL
FD&C BLUE NO. 1
FD&C RED NO. 40
POTASSIUM CITRATE
SOY LECITHIN
SUCRALOSE
SUCROSE
GLUCOSE SYRUP
CITRIC ACID
Water
Package Label.Principal Display Panel
Label (Label)
* Please review the disclaimer below.
