Label: COUGH AND COLD NIGHTTIME REAL RELIEF- drosera, arnica montana, bryonia, cetraria islandica, belladonna, coccus cacti, stannum metallicum, chamomilla, coffea cruda syrup
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Contains inactivated NDC Code(s)
NDC Code(s): 60512-9084-9 - Packager: HOMEOLAB USA 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 December 14, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS HPUS
- PURPOSE
- REFERENCES
- USES
- WARNINGS
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DIRECTIONS
Do not use more than directed.
Do not take with food.
Take before bedtime. Repeat every 8 hours, as needed.
Reduce intake with improvement or as directed by a healthcare professional.
Adults and children 12+ yrs: 2 teaspoons.
Children 6 to 11 years of age: 1 teaspoon.
Children 2 to 5 years of age: 1/2 teaspoon.
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- CARTON
- LABEL
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INGREDIENTS AND APPEARANCE
COUGH AND COLD NIGHTTIME REAL RELIEF
drosera, arnica montana, bryonia, cetraria islandica, belladonna, coccus cacti, stannum metallicum, chamomilla, coffea cruda syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60512-9084 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DROSERA ROTUNDIFOLIA (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA - UNII:QR44N9XPJQ) DROSERA ROTUNDIFOLIA 1 [hp_C] in 250 mL ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 3 [hp_C] in 250 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 3 [hp_C] in 250 mL CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1) (CETRARIA ISLANDICA SUBSP. ISLANDICA - UNII:BJ7YPN79A1) CETRARIA ISLANDICA SUBSP. ISLANDICA 1 [hp_C] in 250 mL ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 3 [hp_C] in 250 mL PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT) PROTORTONIA CACTI 3 [hp_C] in 250 mL TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN 3 [hp_C] in 250 mL MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 4 [hp_C] in 250 mL ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 4 [hp_C] in 250 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:60512-9084-9 1 in 1 CARTON 03/21/2012 1 250 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 03/21/2012 Labeler - HOMEOLAB USA INC (202032533) Establishment Name Address ID/FEI Business Operations HOMEOLAB USA INC 202032533 manufacture(60512-9084)