Otc - Active Ingredient
Active Ingredients HPUS:
Drosera 1C
Arnica Montana 3C
Bryonia 3C
Ipecacuanha 3C
Cetraria islandica 1C
Coccus cacti 3C
Corallium rubrum 3C
Stannum metallicum 3C
Kids Relief Liquid
FDA Label NDC 63388-912
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Laboratoire Atlas Inc for the product Kids Relief (NDC 63388-912). 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, dosage & administration, storage and handling, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
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...........coughs, chills and lessens mucus
The letters "HPUS" indicate that the components in this product are officially
monographed in the Homeopathic Pharmacopoeia of the United States.
Indications & Usage
Uses This homeopathic medicine is made from a
combination of ingredients traditionally used to help
relieve symptoms associated with cough and cold*:
•dry cough •cough with expectoration
•chest congestion •fever •aches and pains
Warnings
Warnings
Stop use and ask a doctor if •pain or cough gets worse or lasts
more than 5 days ( children) or 7 days (adults) •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.
Dosage & Administration
Directions •Children under 6 months of age: Consult
a licensed healthcare practitioner before using this product
•Children 6 months to 2 years old: 2.5ml or 1/2 teaspoon
every 6 hours or 4 times a day •Children 2 to 12 years
old: 5ml or 1 teaspoon, every 6 hours or 4 times a day.
Storage And Handling
Other information •Store at room temperature.
•Do not use if seal is broken or missing.
Inactive Ingredient
Inactive ingredients Purified water, sorbitol,
caramel, sodium benzoate, potassium sorbate, citric acid
Package Label.Principal Display Panel
Image Description (Cough 5)
Image Description (Cough 9)
Image Description (Cough 4)
* Please review the disclaimer below.
