FDA Label for Cough And Cold Real Relief

View Indications, Usage & Precautions

Cough And Cold Real 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

Ipecacuanha (Ipecac) 3C

Cetraria islandica (Iceland moss) 1C

Belladonna (Deadly nightshade) 3C

Coccus cacti (Cochineal) 3C

Corallium rubrum (Red coral) 3C

Stannum metallicum (Tin) 3C


Purpose



Dry cough

Aches and pains, chest congestion

Painful cough

Night cough

Cough with expectoration

Cold and fever

Cough with expectoration

Painful cough

Cough, chills and lessens mucus


References



The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic 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 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 - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of accidenal overdose, contact a medical professional or a poison control center immediately.


Directions



• Do not use more than directed.

• Do not take with food.

• Repeat every 4 hours and reduce intake with improvement or as directed by a health professional.


Age:                                         Dose:

Adults and children 12+ yrs:    2 teaspoons (tsp)

Children 6 to 11 years of age:  1 teaspoon (tsp)

Children 2 to 5 years of age:    1/2 teaspoon (tsp)


Other Information



Store at room temperature.

Do not use if seal is broken or missing.


Inactive Ingredients



Purified water, sorbitol, caramel, sodium benzoate, potassium sorbate, citric acid.


Carton




Label




* Please review the disclaimer below.