Label: WALGREENS BLACK ELDERBERRY COLD AND FLU RELIEF- bryonia alba, gelsemium sempervirens, sambucus nigra, sulphur, zincum gluconicum tablet, orally disintegrating
- NDC Code(s): 0363-9791-14
- Packager: Walgreen Co.
- 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 31, 2023
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Active Ingredients
Active ingredients (In each tablet) *
Bryonia 6X HPUS
Gelsemium sempervirens 6X, 12X, 30X HPUSSambucus nigra 3X, 6X HPUS
Sulphur 12X HPUS
Zincum gluconicum 2X, 6X HPUS*The letters ‘HPUS’ indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
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Purpose
Bryonia HPUS - Fever, chills, scratchy throat, muscle soreness
Gelsemium sempervirens HPUS - Sneezing, non-productive cough, bronchial irritationSambucus nigra HPUS - Fever, nasal congestion, coughing
Sulphur HPUS - Sinus pressure, sore throat, nasal pressure
Zincum gluconicum HPUS - Nausea, tiredness, exhaustion, bronchial constriction -
Uses*
According to homeopathic indications, these ingredients provide temporary relief of cold and flu symptoms such as: • Nasal and sinus congestion, runny nose, sor coughing, sneezing, and chills and fever, after serious causes have been ruled out by a physician.
* These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.
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Warnings
Warnings
A PHYSICIAN SHOULD ALWAYS BE CONSULTED TO RULE OUT SERIOUS CAUSES.
Sore throat warning - Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult phys Do not use more than 2 days or administer to children under 4 years of age unless directed by a physician. • This product is intended to complement, not replace, medical treatment. • Initial worsening of symptoms may occur.
- Pregnant or breast-feeding
- Keep out of reach of children
- Stop use
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Directions
Directions
• Suitable for adults and children ages 4 and over. Children under the age of 4: Consult a physician before use. • For best results, take at the start of the symptoms for cold or flu and continue to take for another 48 hours after the symptoms end. • Dissolve entire tablet under tongue OR chew tablet and swallow. • Do not swallow tablet whole. • Take 1 tablet every three hours. • Take at least 10 minutes before or at least 10 minutes after eating or drinking. • Homeopathic remedies may not be effective for everyone. Individual results may vary.
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Other information
• Do not use if blister seal is broken. • Store at room temperature 15o to 30o C (59o to 86o F). • Active ingredients are micro-diluted in accordance with the Pharmacopoeia of the United States and are therefore non-toxic with no known side effects or contraindications. • Retain carton for full drug facts.
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
WALGREENS BLACK ELDERBERRY COLD AND FLU RELIEF
bryonia alba, gelsemium sempervirens, sambucus nigra, sulphur, zincum gluconicum tablet, orally disintegratingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9791 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE 2 [hp_X] SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X] SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP 3 [hp_X] GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X] BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 6 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) BLACK CARROT ANTHOCYANINS (UNII: 971DA56IOL) MAGNESIUM STEARATE (UNII: 70097M6I30) SUCROSE (UNII: C151H8M554) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) Product Characteristics Color purple (OFF PURPLE OFF GREY COLOR WITH SPECKS) Score score with uneven pieces Shape ROUND Size 10mm Flavor BERRY (ELDERBERRY) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-9791-14 1 in 1 CARTON 05/13/2022 1 60 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 05/13/2022 Labeler - Walgreen Co. (008965063)