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
Camomilla 4C
Coffea crudea 4C
Kids Relief Liquid
FDA Label NDC 71971-9999
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Homeolab International (canada) Inc for the product Kids Relief (NDC 71971-9999). 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.
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.....................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
Indications & Usage
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
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental
overdose, contact a medical professional or a poison
control center immediately.
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: 2.5 ml or 1.2 teaspoon,
every 8 hours or 3 times a day •Children 2 to 12 years
old: 5 ml or 1 teaspoon, every 8 hours or 3 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 (Kids250 9999)
Image Description (Kids100 9999)
* Please review the disclaimer below.
