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

Cetraria islandica 3C

Coccus cacti 3C

Corallium rubrum 3C

Stannum metallicum 3C

Chamomilla 4C

Coffee crudea 4C


Otc - Purpose



Purpose

Drosera 1C...........................dry cough

Arnica Montana 3C.................aches and pains, chest congestion

Bryonia 3C............................painful cough

Cetraria islandica 3C...............cough with expectoration

Coccus cacti 3C......................cough with expectoration

Corallium rubrum 3C...............painful cough

Stannum metallicum 3C...........cough, chills and lessens mucus

Chamomilla 4C.......................restlessness, irritability, nocturnal awakenings

Coffee crudea 4C....................restlessness and sleeplessness

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 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 •Chidren under 6 months of age: Consult

a licensed healthcare professional before using this product

Children 6 months to 2 years old: 2.5ml or 1/2 teaspoon,

every 8 hours or 3 times a day •Children 2 to 12 years

old: 5ml 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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