FDA Label for Cough And Cold Nighttime Formula Kids Relief
View Indications, Usage & Precautions
Cough And Cold Nighttime Formula Kids Relief Product Label
The following document was submitted to the FDA by the labeler of this product Homeolab Usa 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.
Active Ingredients Hpus:
Drosera (Sundew) 1C
Arnica montana (Leopard`s bane) 3C
Bryonia (White bryony) 3C
Cetraria islandica (Iceland moss) 1C
Coccus cacti (Cochineal) 3C
Corallium rubrum (Red coral) 3C
Stannum metallicum (Tin) 3C
Chamomilla (German chamomile) 4C
Coffea cruda (Coffee) 4C
Purpose
Dry cough
Aches and pains, chest congestion
Painful cough, Fever
Cough with expectoration
Cough with expectoration
Painful cough
Mucus, cough and chills
Restlessness, irritability and nocturnal awakenings
Restlessness and sleeplessness
References
The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.
*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.
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
Otc - Stop Use
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 poison control center immediately.
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.
Other Information
• Store at room temperature.
• Do not use if seal under bottle cap is broken or missing.
Inactive Ingredients
Purified water, sorbitol, caramel, sodium benzoate, potassium sorbate, citric acid.
Carton
* Please review the disclaimer below.