The following Structured Product Label (SPL) was submitted to the FDA by Laboratoire Atlas Inc for the product Real Relief (NDC 63388-918). 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:
Drosera 1C (Sundew)
Arnica montana 3C (Leopard's Bane)
Bryonia 3C (White Bryony)
Ipecacuanha 3C (Ipecac)
Cetraria islandica 1C (Iceland Moss)
Coccus cacti 3C (Cochineal)
Corallium rubrum 3C (Red Coral)
Stannum metallicum 3C (Tin)
The letters "HPUS" indicate that the components in this product are officially
monographed in the Homeopathic Pharmacopoeia of the United States
Purpose
Drosera 1C (Sundew)...............................................dry cough
Arnica montana 3C (Leopard's Bane)..........................aches and pains, chest congestion
Bryonia 3C (White Bryony).......................................painful cough
Ipecacuanha 3C (Ipecac).........................................dry cough
Cetraria islandica 1C (Iceland Moss)..........................cough with expectoration
Coccus cacti 3C (Cochineal).....................................cough with expectoration
Corallium rubrum 3C (Red Coral)..............................painful cough
Stannum metallicum 3C (Tin)..................................coughs, chills and lessens mucus
Uses: This homeopathic medicine is made from a combination of
ingredients traditionally used to help symptoms assiciated with
cough and cold* •dry cough •expectorant cough •chest
congestion •fever •aches and pains
Warnings: Stop use and ask a doctor if: •Pain & cough get
worse or last more than 5 days. •Fever gets worse or lasts more
than 3 days •Redness or swelling is present •New symptoms
occur •Cough comes back or occurs with a rash or headache that
lasts. These could be signs of a serious condition.
If you are pregnant or breast-feeding, 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: •Do not exceed recommended dosage. •Do not take with
food •Repeat every 4 hours and reduce with improvement or as directed
by a health professional.
Age................................................................Dose
Adults and children 12+ years...........................10 ml or 2 teaspoons (tsp)
Children 6 to 11 years of age.............................5 ml or 1 teaspoon (tsp)
Children 2 to 5 years of age...............................2.5 ml or 1/2 teaspoon (tsp)
Other information: •Do not use if seal is broken or missing
•Store at room temperature
Inactive Ingredients: Purified water, sorbitol, caramel, sodium benzoate,
potassium sorbate, citric acid
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* Please review the disclaimer below.
