The following Structured Product Label (SPL) was submitted to the FDA by Gmp Laboratories Of America, Inc. for the product Real Relief (NDC 65808-326). 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 - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients HPUS:
Arnica montana (Leopard's bane) 8[hp-X]
Bryonia (White bryony) 8 [hp-X]
Causticum (Hahnmann's causticum) 8 [hp-X]
Cinchona officinalis (Peruvian bark) 8 [hp-X]
Dulcamara (Bittersweet) 8 [hp-X]
Hydrastis canadensis (Golden seal) 8 [hp-X]
Kali bromatum (Potassium bromide) 8 [hp-X]
Sulphur (Sublimed sulfur) 8 [hp-X]
Purpose
Homeopathic remedy helps relieve symptoms of tinnitus:
The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Uses
This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated
Warnings
Stop use and ask a doctor if symptoms worsen or last for more than 7 days.
If you are pregnant or breastfeeding, ask a health professional before use.
Keep out of reach of children.
In case of accidental overdose, contact a medical professional or poison control center immediately.
Directions
Chew tablets and let dissolve in mouth.
Do not use more than directed.
Do not take with food.
Repeat 3 times daily and reduce intake with improvement or as directed by a health professional
Age…………………………………………………………........ Dose
Adults and Children 12 years of age and older………...... 2 tablets
Children 2 to 11 years of age…...……………………............ 1 tablet
Children under 2 years of age……………………................. Ask a doctor
Other information
Inactive ingredients
Lactose, Magnesium Stearate.
Label1 (Tinnitus 90label 0120)
Label2 (Tinnitus 60label 0120)
Label3 (Tinnitus 30label 0120)
Label4 (Box Realrlf Tinnitus 90tablets 0120)
Label5 (Box Realrlf Tinnitus 60tablets 0120)
* Please review the disclaimer below.
