Label: ZICAM COLD AND FLU-LIKE SYMPTOMS ECHINACEA PLUS SAMBUCUS- zinc acetate anhydrous, zinc gluconate, echinacea angustifolia whole, and sambucus nigra flowering top tablet, multilayer
- NDC Code(s): 10237-479-20
- Packager: CHURCH AND DWIGHT CO, 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 June 5, 2023
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- SPL UNCLASSIFIED SECTION
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ACTIVE INGREDIENT
Active Ingredients (in each tablet) Purpose - *
- Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Echinacea angustifolia 5x Helps to relieve cold and flu-like symptoms* Sambucus nigra (elderberry) 5x Helps to relieve cold and flu-like symptoms* Zincum aceticum 2x
Zincum gluconicum 1xReduces duration of the common cold and helps relieve nasal congestion - Uses
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Warnings
Sore throat warning
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomitting, consult a doctor promptly.
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Directions
- for best results, use at the first sign of cold and flu and continue to use until symptoms completely subside.
- adults and children 12 years of age and older:
- take 1 tablet at the onset of symptoms.
- dissolve entire tablet in mouth. Do not chew. Do not swallow whole.
- repeat every 2 – 3 hours, not to exceed 7 tablets in 24 hours. Take until symptoms are gone.
- to avoid minor stomach upset, do not take on an empty stomach.
- do not eat or drink for 15 minutes after use. Do not eat or drink citrus fruits or juices for 30 minutes before or after use. Otherwise, drink plenty of fluids.
- children under 12 years of age: ask a doctor before use.
- Other information
- Inactive ingredients
- Questions? Comments?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton
NEW!
ZICAM®COLD & FLU-LIKE SYMPTOMS‡
ECHINACEA + SAMBUCUS
HELPS
WITH
6
SYMPTOMS‡✓ COUGH
✓ HOARSENESS✓ SORE THROAT
✓ BODY ACHES✓ CHEST CONGESTION
✓ FEVER & CHILLSPlus Zinc to help relieve nasal congestion
HOMEOPATHIC
20
QUICK-DISSOLVE
TABLETSCOOLING
PEPPERMINT FLAVOR‡Claims based on traditional homeopathic practice,
not accepted medical evidence. Not FDA evaluated. -
INGREDIENTS AND APPEARANCE
ZICAM COLD AND FLU-LIKE SYMPTOMS ECHINACEA PLUS SAMBUCUS
zinc acetate anhydrous, zinc gluconate, echinacea angustifolia whole, and sambucus nigra flowering top tablet, multilayerProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-479 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC ACETATE ANHYDROUS (UNII: H2ZEY72PME) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 2 [hp_X] ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE 1 [hp_X] ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA WHOLE - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA WHOLE 5 [hp_X] SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP 5 [hp_X] Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MANNITOL (UNII: 3OWL53L36A) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color ORANGE, BLUE Score no score Shape ROUND Size 15mm Flavor PEPPERMINT Imprint Code ZZ Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-479-20 1 in 1 CARTON 07/01/2023 1 20 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 07/01/2023 Labeler - CHURCH AND DWIGHT CO, INC. (001211952) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 833150803 MANUFACTURE(10237-479) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 MANUFACTURE(10237-479) , PACK(10237-479) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 MANUFACTURE(10237-479) , PACK(10237-479) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 MANUFACTURE(10237-479) , PACK(10237-479) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 MANUFACTURE(10237-479) , PACK(10237-479)