Label: ZICAM COLD REMEDY RAPIDMELTS WITH ECHINACEA- zinc acetate anhydrous, echinacea angustifolia, and zinc gluconate tablet
- NDC Code(s): 10237-477-25
- Packager: CHURCH & 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 January 24, 2023
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ACTIVE INGREDIENT
Active ingredients (in each tablet) Purpose - *
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Claims based on traditional homeopathic practice, not accepted medical evidence.
Not FDA evaluated.
Echinacea angustifolia 5x Helps relieve stuffy nose* Zincum aceticum 2x
Zincum gluconicum 1xReduces duration of the common cold and helps relieve nasal congestion - Uses
- Warnings
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Directions
- for best results, use at the first sign of a cold 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
- PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Carton
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INGREDIENTS AND APPEARANCE
ZICAM COLD REMEDY RAPIDMELTS WITH ECHINACEA
zinc acetate anhydrous, echinacea angustifolia, and zinc gluconate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-477 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] ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA WHOLE - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA WHOLE 5 [hp_X] ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE 1 [hp_X] Inactive Ingredients Ingredient Name Strength ascorbic acid (UNII: PQ6CK8PD0R) CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) FD&C Yellow No. 5 (UNII: I753WB2F1M) aluminum oxide (UNII: LMI26O6933) magnesium stearate (UNII: 70097M6I30) mannitol (UNII: 3OWL53L36A) ammonium glycyrrhizate (UNII: 3VRD35U26C) stearic acid (UNII: 4ELV7Z65AP) sucralose (UNII: 96K6UQ3ZD4) sodium starch glycolate type a potato (UNII: 5856J3G2A2) Product Characteristics Color YELLOW (light yellow) Score no score Shape ROUND (cup-shaped) Size 15mm Flavor LEMON, LIME Imprint Code Z Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-477-25 1 in 1 CARTON 08/26/2022 1 25 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 08/26/2022 Labeler - CHURCH & DWIGHT CO., INC. (001211952) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 833150803 MANUFACTURE(10237-477) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 MANUFACTURE(10237-477) , PACK(10237-477) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 MANUFACTURE(10237-477) , PACK(10237-477) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 MANUFACTURE(10237-477) , PACK(10237-477) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 MANUFACTURE(10237-477) , PACK(10237-477)