Advanced Cherry Flavored Cough Drops
FDA Label NDC 67060-120

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced First Aid, Inc. for the product Advanced Cherry Flavored Cough Drops (NDC 67060-120). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient (in each tablet) - Menthol 7.6g

Otc - Purpose

antitussive/cough suppressant

Indications & Usage

Uses: temporarily relieves these symptoms as may occur with colds or inhaled irritants: • cough • sore throat

Warnings

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

• cough that occurs with excessive phlegm (mucus)

Stop use and ask a doctor if: • cough persists for more than a week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistant cough may be a sign of a serious condition.

• sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, vomiting

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding baby, ask a health professional before use. 

Otc - Keep Out Of Reach Of Children

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

Dosage & Administration

Directions:

• Adults and children 5 years and over: 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

artificial cherry flavor, corn syrup, eucalyptus oil, FD& C red #40, sucrose

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