The following Structured Product Label (SPL) was submitted to the FDA by Laboratoire Atlas Inc for the product Real Relief (NDC 63388-989). 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 (Leopards Bane)
Bryonia 3C (Whte Bryony)
Ipecacuanha 3C (Ipecac)
Cetraria islandica 1C (Iceland Moss)
Coccus cacti 3C (Cochineal)
Corallium rubrum 3C (Red Coral)
Stannum metallicum 3C (Tin)
Camomilla 4C (German Chamomille)
Coffea crudea 4C (coffee)
Purpose
Drosera 1C......................................dry cough
Arnica montana 3C...........................aches and pains, chest congestion
Bryonia 3C......................................painful cough
Ipecacuanha 3C...............................night cough
Cetraria islandica 1C.........................cough with expectoration
Coccus cacti 3C................................cough with expectoration
Corallium rubrum 3C.........................painful cough
Stannum metallicum 3C.....................cough, chills, and lessens mucus
Camomilla 4C...................................restlessness, irritability, nocturnal awakenings
Coffea crudea 4C..............................restlessness and sleeplessness
The letters "HPUS" indicate that the components in this product are officially
monographed in the Homeopathic Pharcopoeia of the United States
Uses This homeopathic medicine is made from a combination
of ingredients traditionally used to help relieve
symptoms associated with nighttime cough and cold*:
•dry cough •cough with expectoration
•chest congestion •fever •aches and pains
Warnings
Stop use and ask a doctor if •Pain & cough gets worse
or lasts 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 rash or headache that lasts.
These could be signs of a serious condition
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 a poison
control center immediately.
Directions •Do not exceed recommended dosage •Do not take with
food •Take before bedtime. Repeat every 8 hours as needed and reduce
with improvement or as directed by a health care 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
Image Description (Rr250 9899)
* Please review the disclaimer below.
