Label: COMPARE2 BLACK ELDERBERRY COLD AND FLU RELIEF- bryonia, gelsemium sempervirens, sambucus nigra, sulphur, zincum gluconicum tablet, orally disintegrating
- NDC Code(s): 17312-077-30
- Packager: TRP COMPANY
- Category: HUMAN PRESCRIPTION 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 10, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
ACTIVE INGREDIENT
Active Ingredients (In each tablet):
Bryonia 6X HPUS, Gelsemium sempervirens 6X, 12X, 30X HPUS, Sambucus 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.
-
INDICATIONS & USAGE
Uses*
According to homeopathic indications, these ingredients provide temporary relief of cold and flu symptoms such as: • Nasal and sinus congestion, runny nose, sore throat, 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.
-
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 physician promptly. 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, standard medical treatment. • Initial worsening of symptoms may occur. • A physician should always be consulted to rule out serious causes.
If pregnant or breast feeding, ask a health professional before using.
-
DOSAGE & ADMINISTRATION
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. • Do not chew or swallow 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.
-
OTHER SAFETY INFORMATION
Other Information
• Do not use if blister seal is broken. • Store at room temperature 15 o to 30 o C (59 o to 86 o F). • Active ingredients are micro-diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects or contraindications. • Retain carton for full drug facts.
- INACTIVE INGREDIENT
-
PRINCIPAL DISPLAY PANEL
NDC 17312-077-30
Bryonia 6X HPUS.................................................Fever, chills, scratchy throat, muscle soreness
Gelsemium sempervirens 6X, 12X, 30X HPUS....Sneezing, non-productive cough, bronchial irritation
Sambucus nigra 3X, 6X HPUS.............................Fever, nasal congestion, coughing
Sulphur 12X HPUS...............................................Sinus pressure, sore throat, nasal pressure
Zincum gluconicum 2X, 6X HPUS........................Nausea, tiredness, exhaustion, bronchial constriction -
INGREDIENTS AND APPEARANCE
COMPARE2 BLACK ELDERBERRY COLD AND FLU RELIEF
bryonia, gelsemium sempervirens, sambucus nigra, sulphur, zincum gluconicum tablet, orally disintegratingProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17312-077 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] GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X] SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP 3 [hp_X] SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X] ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE 2 [hp_X] Inactive Ingredients Ingredient Name Strength BLACK CARROT ANTHOCYANINS (UNII: 971DA56IOL) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SUCROSE (UNII: C151H8M554) EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E) Product Characteristics Color purple (off purple) Score no score Shape ROUND Size 10mm Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17312-077-30 1 in 1 BOX 05/20/2020 1 30 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 05/20/2020 Labeler - TRP COMPANY (105185719) Registrant - TRP COMPANY (105185719)