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  5. Label Information: Kids Relief Cough And Cold Syrup Combo Pack Daytime Formula And Nighttime Formula

FDA Label for Kids Relief Cough And Cold Syrup Combo Pack Daytime Formula And Nighttime Formula

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. PRODUCT LABEL

Kids Relief Cough And Cold Syrup Combo Pack Daytime Formula And Nighttime Formula 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.

Active Ingredients



Part 1 -Cough Cold Daytime Syrup

DROSERA ROTUNDIFOLIA FLOWERING TOP
ARNICA MONTANA
BRYONIA ALBA WHOLE
IPECACUANHA (IPECAC)
CETRARIA ISLANDICA SUBSP. ISLANDICA
COCHINEAL (COCCUS CACTI)
CORALLIUM RUBRUM WHOLE
STANNUM METALLICUM (TIN)

Part 2 -Cough Cold Nighttime Syrup

DROSERA ROTUNDIFOLIA FLOWERING TOP
ARNICA MONTANA
BRYONIA ALBA WHOLE
CETRARIA ISLANDICA SUBSP. ISLANDICA
COCHINEAL (COCCUS CACTI)
CORALLIUM RUBRUM WHOLE
STANNUM METALLICUM (TIN)
CHAMOMILLA (GERMAN CHAMOMILLE)
COFFEA CRUDA (COFFEE)


Purpose



Part 1 - Cough Cold Daytime Syrup


DROSERA ROTUNDIFOLIA FLOWERING TOP                  Dry Cough
ARNICA MONTANA                                                              Aches and Pain , Chest Congestion
BRYONIA ALBA WHOLE                                                       Painful Cough
IPECACUANHA (IPECAC)                                                   Night Cough
CETRARIA ISLANDICA SUBSP. ISLANDICA                     Cough With Expectoration
COCHINEAL (COCCUS CACTI)                                     Cough With Expectoration
CORALLIUM RUBRUM WHOLE                                        Painful cough
STANNUM METALLICUM (TIN)                                       Cough, Chills and Lessen mucus

Part 2 - Cough Cold Nighttime Syrup


DROSERA ROTUNDIFOLIA FLOWERING TOP                        Dry Cough
ARNICA MONTANA                                                                    Aches and Pain , Chest Congestion
BRYONIA ALBA WHOLE                                                             Painful Cough
CETRARIA ISLANDICA SUBSP. ISLANDICA                             Cough With Expectoration
COCHINEAL (COCCUS CACTI)                                              Cough With Expectoration
CORALLIUM RUBRUM WHOLE                                              Painful cough
STANNUM METALLICUM (TIN)                                               Cough, Chills and Lessen mucus
CHAMOMILLA (GERMAN CHAMOMILLE)                               Restlessness, irritability and nocturnal awakening
COFFEA CRUDA (COFFEE)                                                       Restlessness and sleeplessness

The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.


Uses



T his ho meo pathic medicine is made from a combination of ingredients traditionally used to help symptoms associated with nighttime cough and cold*; dry cough, cough with expectorantion, chest congestion, aches and pain,fever.

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Warnings



Stop use and ask a doctor if: • Pain & cough get worse or last 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.

Keep out of reach of children. In case of accidental overdose, contact a medical

professional or poison control center immediately.


Otc - Keep Out Of Reach Of Children




Directions



Part 1 Kids Relief Daytime Syrup

Children under 6 months of age: consult a licensed healthcare practitioner before using the product. Children 6 months to 2 years old: 2.5 ml or ½ teaspoon, every 6 hours or 4 times a day. Children 2 to 12 years old: 5 ml or 1 teaspoon, every 6 hours or 4 times a day.

Part 2 Kids Relief Nighttime Syrup

Children under 6 months of age: consult a licensed healthcare practitioner before using the product. Children 6 months to 2 years old: 2.5 ml or ½ 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



Part 1

Do not use if the seal is broken or missing. Store at room temperature.

Part 2

Store at room temperature.• Do not use if seal is broken or missing

*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice, not medical evidence.


Inactive Ingredients



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


Product Label



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image description - image 1


* Please review the disclaimer below.