Guna-reflux Solution/ Drops
FDA Label NDC 17089-406

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-reflux (NDC 17089-406). 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

AETHUSA CYNAPIUM        4X    DIGESTIVE
APOMORPHINE HYDROCHLORIDE    6X    PAIN
BRYONIA ALBA            4X, 10X, 30X, 200X    ANTITUSSIVE
CARBO VEGETALIS            12X    ANTITUSSIVE
CARDIA VENTRICULI        10X    GAS
COLCHICUM AUTUMNALE        6X    ANTI-INFLAMMATORY
COLOCYNTHIS             5X, 10X, 30X, 200X    NERVOUS IRRITATION
ESOPHAGUS            10X    DIGESTIVE
IGNATIA AMARA            6X    ANTISTRESS
IPECACUANHA             4X    ANTITUSSIVE
LYCOPODIUM CLAVATUM        5X, 10X, 30X, 200X    DETOXIFICATION
NUX VOMICA             4X, 10X, 30X, 200X    ACID REFLUX

Uses


Helps relieving GERD symptoms such as: occasional heartburn, regurgitation, acid taste in the mouth.

Warnings

Stop use and ask doctor if symptoms of heartburn, regurgitation or cough worsen or persist more than 5 days

Keep this and all medicines out of reach of children

Pregnancy

If pregnant or breast-feeding ask a doctor before use

Directions

Take 15 minutes before meals
Adults and children 12 years and older    10 drops in a little water 3 times per day
Children between 12 years and 6 years of age    7 drops in a little water 3 times per day
Children under 6 years    5 drops in a glass of water 3 times per day

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