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 Laboratoire Atlas 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


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




* Please review the disclaimer below.