Label: REAL RELIEF NATURAL WELLNESS COUGH AND COLD SYRUP COMBO PACK DAYTIME FORMULA AND NIGHTTIME FORMULA (drosera rotundifolia flowering top, arnica montana, bryonia alba whole, ipecacuanha (ipecac), cetraria islandica subsp. islandica, cochineal (coccus cacti), corallium rubrum whole, stannum metallicum (tin), chamomilla (german chamomille), coffea cruda- coffee kit
- NDC Code(s): 71971-6155-7, 71971-9185-5, 71971-9204-5
- Packager: Homeolab International (Canada) inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated January 25, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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Active Ingredients
Part 1 -Real Relief Natural Wellness™ 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 - Real Relief Natural Wellness™ 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 - Real Relief Natural Wellness™ Cough Cold Daytime Syrup
DROSERA ROTUNDIFOLIA FLOWERING TOP Dry Cough
ARNICA MONTANA Aches and Pain , Chest Congestion
BRYONIA ALBA WHOLE Painful Cough
IPECACUANHA (IPECAC) Dry 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 mucusPart 2 - Real Relief Natural Wellness™ 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 sleeplessnessThe letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.
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Uses
T his ho meo pathic medicine is made from a combination of ingredients traditionally used to help symptoms associated with cough and cold*; dry cough, expectorant cough, chest congestion, fever, aches and pain.
*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice, not medical evidence.
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Warnings
Stop use and ask a doctor if: • Pain & cough get worse or last more than 5 days. • 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.
If you are pregnant or breast feeding, ask a health professional before.
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
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Directions
Part 1 Real Relief Natural Wellness™ Daytime Syrup
Directions:
• Do not exceed recommended dosage
• Do not take with foods
• Repeat every 4 hours and reduce with improvement or as directed by a health professional.
Age………………………………………………………….Dose
Adults and Children 12 + years. ...........10 ml or 2 teaspoon (tsp)
Children 6 to 11 years of age. ...............5 ml or 1 teaspoon (tsp)
Children 2 to 5 years of age. .................2.5 ml or ½ teaspoon (tsp)Part 2 Real Relief Natural Wellness™ Relief Nighttime Syrup
Directions:
• Do not exceed recommended dosage
• Do not take with foods
• Repeat every 8 hours and reduce with improvement or as directed by a health professional.
Age………………………………………………………….Dose
Adults and Children 12 + years. ............10 ml or 2 teaspoon (tsp)
Children 6 to 11 years of age. ................5 ml or 1 teaspoon (tsp)
Children 2 to 5 years of age. ..................2.5 ml or ½ teaspoon (tsp) -
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
- Product label
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INGREDIENTS AND APPEARANCE
REAL RELIEF NATURAL WELLNESS COUGH AND COLD SYRUP COMBO PACK DAYTIME FORMULA AND NIGHTTIME FORMULA
drosera rotundifolia flowering top, arnica montana, bryonia alba whole, ipecacuanha (ipecac), cetraria islandica subsp. islandica, cochineal (coccus cacti), corallium rubrum whole, stannum metallicum (tin), chamomilla (german chamomille), coffea cruda (coffee) kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71971-6155 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71971-6155-7 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 REAL RELIEF
drosera, bryonia, ipecacuanha, cetraria islandica, coccus cacti, corallium rubrum, stannum metallicum liquidProduct Information Item Code (Source) NDC:71971-9185 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 PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT) PROTORTONIA CACTI 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:71971-9185-5 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 REAL RELIEF
drosera, arnica montana, bryonia, cetraria islandica, coccus cacti, corallium rubrum, stannum metallicum, camomilla, coffea crudea liquidProduct Information Item Code (Source) NDC:71971-9204 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 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 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 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:71971-9204-5 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)