Cough Drops Liquid
FDA Label NDC 63083-2014

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Professional Complementary Health Formulas for the product Cough Drops (NDC 63083-2014). 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 active ingredients, questions, indications, otc - purpose, warnings, otc - keep out of reach of children, otc - pregnancy or breast feeding, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Spongia tosta 2X
Belladonna 3X
Ipecacuanha 3X
Rumex crispus 3X
Senega officinalis 3X
Kali sulphuricum 4X
Mentha piperita 4X
Pulsatilla 4X
Arsenicum iodatum 6X
Drosera rotundifolia 6X
Hepar sulphuris calcareum 6X
Sanguinaria canadensis 6X
Bryonia 12X
Kali bichromicum 12X

Questions

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

Indications

Temporarily reduces the intensity of coughing.*

Otc - Purpose

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings

A persistent cough may be a sign of a serious condition. If cough persists, tends to recur, or is accompanied by a fever, rash, or other symptoms, consult a doctor. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a healthcare professional before use.

Directions

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day for up to 6 weeks. For immediate onset of symptoms, take 10 to 15 drops every 15 minutes up to 3 hours. For less severe symptoms, take 10-15 drops hourly up to 8 hours. Consult a physician for use in children under 12 years of age.

Other Information

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

Inactive Ingredients

20% ethanol, purified water.

Label

Est 1985

Professional Formulas

Complementary Health

Cough Drops

Homeopathic Remedy

2 FL. OZ. (59 mL)

Label Image (C14 Thumb)

Label Image (C14 Thumb)

* Please review the disclaimer below.