FDA Label for Advanced Honey Lemon Cough Drops

View Indications, Usage & Precautions

Advanced Honey Lemon Cough Drops Product Label

The following document was submitted to the FDA by the labeler of this product Advanced First Aid, Inc.. 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 8.6mg


Otc - Purpose



Cough suppressant / Oral Anesthetic


Indications & Usage



Uses: temporarily relieves • cough as may occur with a cold • occasional minor irritation and sore throat


Warnings



Warnings:

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These smptoms may be serious.

Ask a doctor before use if you have: • persistent or chronic cough such as ocurs with smoking, asthma, or emphysema

• cough accompanied by excessive phlegm (mucus)

Stop use and consult a doctor if: 

• cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

• sore throat is severe, or irritation, pain or redness lasts or worsens

• sore mouth does not improve in 7 days


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding babyask a health professional before use. 


Otc - Keep Out Of Reach Of Children



KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. In case of accidental overdose, get medical help or contact a Poison Control Center right away.


Dosage & Administration



Directions:

• Adults and children 5 years and older: Allow lozenge to dissolve slowly in mouth; may be repeated every hour as necessary or as directed by a doctor.

Children under 5 years: Consult a doctor.


Inactive Ingredient



corn syrup, eucalyptus oil, D&C Yellow #10, FD& C Yellow #6, honey, lemon oil, sucrose


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