Label: SAMBUCOL COLD AND FLU RELIEF- bryonia, gelsemium sempervirens, sabucus nigra, sulphur, zincum gluconicum tablet, orally disintegrating
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Contains inactivated NDC Code(s)
NDC Code(s): 52053-0001-4 - Packager: PharmaCare US, Inc.
- Category: HUMAN OTC DRUG LABEL
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 April 12, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
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Purpose
Bryonia 6X................Muscle ache, headache, dry throat, cough
Gelsemium sempervirens 6X, 12X, 30X.......................Sneezing
Sambucus nigra 3X, 6X...................Nasal congestion, coughing
Sulphur 12X....................Nasal congestion and pressure, headache
Zincum gluconicum 2X, 6X..........................Fatigue, nausea, minor sore throat
* The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
- Uses
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Warnings
Sore throat warning - Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly.
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Directions
For best results, use at the first sign of symptoms of a cold or flu and continue to use for an additional 48 hours after symptoms subside.
Adults and children 4 years of age and older - Dissolve entire tablet in mouth. Do not chew. Do not swallow whole. Take one tablet at the outset of symptoms. Repeat every three hours.
- Other Information
- Inactive Ingredients
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PRINCIPAL DISPLAY PANEL
NDC# 52053-0001-4
Sambucol
Black Elderberry
Cold & Flu Relief
90 Count Family Pack
Take at the first sign of cold and flu symptoms
**Temporary relief from:
- Nasal & sinus congestion
- Runny nose
- Sore throat
- Coughing
- Sneezing
90 Tablets
Homeopathic
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
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INGREDIENTS AND APPEARANCE
SAMBUCOL COLD AND FLU RELIEF
bryonia, gelsemium sempervirens, sabucus nigra, sulphur, zincum gluconicum tablet, orally disintegratingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52053-0001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 6 [hp_X] in 1 mg SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP 3 [hp_X] in 1 mg GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X] in 1 mg ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE 2 [hp_X] in 1 mg SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X] in 1 mg Inactive Ingredients Ingredient Name Strength BLACK CARROT ANTHOCYANINS (UNII: 971DA56IOL) MAGNESIUM STEARATE (UNII: 70097M6I30) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E) MALTODEXTRIN (UNII: 7CVR7L4A2D) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SUCROSE (UNII: C151H8M554) Product Characteristics Color purple (off purple off grey color with specks) Score no score Shape ROUND Size 10mm Flavor BERRY (Elderberry) Imprint Code SCF Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52053-0001-4 6 in 1 CARTON 10/15/2021 1 4500 mg in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/15/2021 Labeler - PharmaCare US, Inc. (026889965) Establishment Name Address ID/FEI Business Operations Nutritional Laboratories International Inc 007306970 manufacture(52053-0001) Establishment Name Address ID/FEI Business Operations Ion Labs Inc 106499791 pack(52053-0001)