KIDS RELIEF COUGH AND COLD SYRUP COMBO PACK DAYTIME FORMULA AND NIGHTTIME FORMULA- drosera rotundifolia flowering top, arnica montana, bryonia alba whole, ipecacuanha, cetraria islandica subsp. islandica, cochineal, corallium rubrum whole, stannum metallicum, chamomilla, coffea cruda kit

Kids Relief Cough and Cold Syrup Combo Pack Daytime Formula and Nighttime Formula by

Drug Labeling and Warnings

Kids Relief Cough and Cold Syrup Combo Pack Daytime Formula and Nighttime Formula by is a Homeopathic medication manufactured, distributed, or labeled by Homeolab International (Canada) inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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

INGREDIENTS AND APPEARANCE

KIDS RELIEF COUGH AND COLD SYRUP COMBO PACK DAYTIME FORMULA AND NIGHTTIME FORMULA 
drosera rotundifolia flowering top, arnica montana, bryonia alba whole, ipecacuanha, cetraria islandica subsp. islandica, cochineal, corallium rubrum whole, stannum metallicum, chamomilla, coffea cruda kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71971-6105

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71971-6105-7	1 in 1 KIT; Type 0: Not a Combination Product	09/01/2022

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	100 mL
Part 2	1 BOTTLE	100 mL

Part 1 of 2

KIDS RELIEF 
drosera, arnica montana, bryonia, ipecacuanha, cetraria islandica, coccus cacti, corallium rubrum, stannum metallicum liquid

Product Information
Item Code (Source)	NDC: 71971-9121
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DROSERA ROTUNDIFOLIA FLOWERING TOP (UNII: 75O014T1HG) (DROSERA ROTUNDIFOLIA FLOWERING TOP - UNII:75O014T1HG)	DROSERA ROTUNDIFOLIA FLOWERING TOP	1 [hp_C]  in 100 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	3 [hp_C]  in 100 mL
BRYONIA ALBA WHOLE (UNII: 56K0VVT47P) (BRYONIA ALBA WHOLE - UNII:56K0VVT47P)	BRYONIA ALBA WHOLE	3 [hp_C]  in 100 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	3 [hp_C]  in 100 mL
CETRARIA ISLANDICA WHOLE (UNII: BJ7YPN79A1) (CETRARIA ISLANDICA WHOLE - UNII:BJ7YPN79A1)	CETRARIA ISLANDICA WHOLE	1 [hp_C]  in 100 mL
COCHINEAL (UNII: TZ8Z31B35M) (COCHINEAL - UNII:TZ8Z31B35M)	COCHINEAL	3 [hp_C]  in 100 mL
CORALLIUM RUBRUM WHOLE (UNII: 22Z32PWR7R) (CORALLIUM RUBRUM WHOLE - UNII:22Z32PWR7R)	CORALLIUM RUBRUM WHOLE	3 [hp_C]  in 100 mL
TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5)	TIN	3 [hp_C]  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARAMEL (UNII: T9D99G2B1R)
SORBITOL (UNII: 506T60A25R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71971-9121-5	1 in 1 CARTON
1		100 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/01/2022

Part 2 of 2

KIDS RELIEF 
drosera, arnica montana, bryonia, cetraria islandica, coccus cacti, corallium rubrum, stannum metallicum, chamomilla, coffee crudea liquid

Product Information
Item Code (Source)	NDC: 71971-9151
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DROSERA ROTUNDIFOLIA FLOWERING TOP (UNII: 75O014T1HG) (DROSERA ROTUNDIFOLIA FLOWERING TOP - UNII:75O014T1HG)	DROSERA ROTUNDIFOLIA FLOWERING TOP	1 [hp_C]  in 100 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	3 [hp_C]  in 100 mL
BRYONIA ALBA WHOLE (UNII: 56K0VVT47P) (BRYONIA ALBA WHOLE - UNII:56K0VVT47P)	BRYONIA ALBA WHOLE	3 [hp_C]  in 100 mL
CETRARIA ISLANDICA WHOLE (UNII: BJ7YPN79A1) (CETRARIA ISLANDICA WHOLE - UNII:BJ7YPN79A1)	CETRARIA ISLANDICA WHOLE	1 [hp_C]  in 100 mL
PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT)	PROTORTONIA CACTI	3 [hp_C]  in 100 mL
TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5)	TIN	3 [hp_C]  in 100 mL
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	4 [hp_C]  in 100 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	4 [hp_C]  in 100 mL
CORALLIUM RUBRUM WHOLE (UNII: 22Z32PWR7R) (CORALLIUM RUBRUM WHOLE - UNII:22Z32PWR7R)	CORALLIUM RUBRUM WHOLE	3 [hp_C]  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
CARAMEL (UNII: T9D99G2B1R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71971-9151-5	1 in 1 CARTON
1		100 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/01/2022

Labeler - Homeolab International (Canada) inc (203639455)