Guna-cough Solution/ Drops
FDA Label NDC 17089-453

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Guna Spa for the product Guna-cough (NDC 17089-453). 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/purpose, uses, warnings, pregnancy, directions, questions, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients/Purpose

ALTHAEA OFFICINALIS    1X    EXPECTORANT
ANTIMONIUM TARTARICUM    8X    ANTITUSSIVE, DRY COUGH
BRYONIA ALBA                6X    ANTI-INFLAMMATORY
CETRARIA ISLANDICA      4X    EXPECTORANT
COCCUS CACTI                6X    ANTITUSSIVE, WET COUGH
CUPRUM ACETICUM        8X    PAIN RELIEF
DROSERA                       1X    COUGH SUPPRESSANT, SPASMODIC COUGH
ECHINACEA ANGUSTIFOLIA    1X    IMMUNE SUPPORT
PLANTAGO MAJOR        1X    EXPECTORANT
STICTA PULMONARIA    4X    ANTITUSSIVE
THYME                          1X    EXPECTORANT

Uses

For the temporary relief of coughs due to minor throat and bronchial irritation from inhaled irritants. Helps loosen phlegm (mucous) and thin bronchial secretions to make coughs more productive

Warnings

Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or a cough accompanied by too much phlegm (mucus). Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

Keep this and all medicines out of reach of children

Pregnancy

If pregnant or breast-feeding ask a doctor before use

Directions

Use enclosed dosage cup for dosing
Adults and children 12 years and older    10 ml  every 4 hours as needed
Children between 12 years and 2 years of age    5 ml  every 4 hours as needed
Children under 2 years     Ask a physician

Principal Display Panel

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