FDA Label for Kids Relief

View Indications, Usage & Precautions

Kids Relief Product Label

The following document was submitted to the FDA by the labeler of this product Homeolab International (canada) Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


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




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