FDA Label for Cough Drops
View Indications, Usage & Precautions
Cough Drops Product Label
The following document was submitted to the FDA by the labeler of this product Xinsanyang Pharmaceutical (xiamen) Co., Ltd.. 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.
Other
Cough Drops
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
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