Label: PLANTAIN SPRUCE COUGH liquid
- NDC Code(s): 48951-8390-1
- Packager: Uriel Pharmacy 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 24, 2024
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- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
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ACTIVE INGREDIENT
Active Ingredients: 100 gm contains: 30 gm Plantago (Ribwort plantain) 1X, 15 gm Picea abies (Spruce) 1X,
2.5 gm Petasites (Butterbur) 1X, 2.5 gm Prunus (Blackthorn) 1X; Drosera (Sundew) 4X, Atropa belladonna (Nightshade) 5X,
China (Peruvian bark) 5X, Coccus cacti (Cochineal bug, female) 5X, Helleborus (Christmas rose) 5X, |pecacuanha (Ipecac) 5X,
Veratrum (White hellebore) 5X, Mephitis (Secretion from the rectal gland of skunk) 7X - INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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WARNINGS
Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist.
If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.SHAKE WELL BEFORE USE. REFRIGERATE AFTER OPENING.
BEST WHEN USED WITHIN 90 DAYS OF OPENING. - QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PLANTAIN SPRUCE COUGH
plantain spruce cough liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48951-8390 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 5 [hp_X] in 1 mL CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 5 [hp_X] in 1 mL PICEA ABIES WHOLE (UNII: D77PG8S4KK) (PICEA ABIES WHOLE - UNII:D77PG8S4KK) PICEA ABIES WHOLE 1 [hp_X] in 1 mL PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT) PROTORTONIA CACTI 5 [hp_X] in 1 mL IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC 5 [hp_X] in 1 mL PETASITES HYBRIDUS ROOT (UNII: 97S2809V5R) (PETASITES HYBRIDUS ROOT - UNII:97S2809V5R) PETASITES HYBRIDUS ROOT 1 [hp_X] in 1 mL SLOE (UNII: 3MLB4858X7) (SLOE - UNII:3MLB4858X7) SLOE 1 [hp_X] in 1 mL PLANTAGO LANCEOLATA WHOLE (UNII: TJ55Y9N2M4) (PLANTAGO LANCEOLATA WHOLE - UNII:TJ55Y9N2M4) PLANTAGO LANCEOLATA WHOLE 1 [hp_X] in 1 mL MEPHITIS MEPHITIS ANAL GLAND FLUID (UNII: 3BN57UN4US) (MEPHITIS MEPHITIS ANAL GLAND FLUID - UNII:3BN57UN4US) MEPHITIS MEPHITIS ANAL GLAND FLUID 7 [hp_X] in 1 mL HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815) HELLEBORUS NIGER ROOT 5 [hp_X] in 1 mL VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT 5 [hp_X] in 1 mL DROSERA ROTUNDIFOLIA (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA - UNII:QR44N9XPJQ) DROSERA ROTUNDIFOLIA 4 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) VANILLA (UNII: Q74T35078H) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) CHERRY (UNII: BUC5I9595W) BEET TOP (UNII: YB1P778Q1C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48951-8390-1 125 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 01/12/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/12/2022 Labeler - Uriel Pharmacy Inc. (043471163) Establishment Name Address ID/FEI Business Operations Uriel Pharmacy Inc. 043471163 manufacture(48951-8390)
