Label: FIRST AID DIRECT COLD-EEZE COLD REMEDY- zinc gluconate lozenge
- NDC Code(s): 42961-105-01, 42961-105-02
- Packager: Cintas Corporation
- 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 July 20, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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Warnings
Do not use for treatment of influenza or allergies. This product is intended only to reduce the duration of the common cold and its symptoms
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DOSAGE & ADMINISTRATION
Directions
- take one lozenge at the onset of symptoms
- dissolve entire lozenge in mouth
- do not chew
- do not swallow whole
- do not eat or drink for 15 minutes after use
- repeat every 2-4 hours until symptoms subside
- Adults 18 years and over: do not exceed 6 lozenges per day
- Children 12 to under 18 years: do not exceed 4 lozenges per day
- Children under 12 years: ask a doctor before use
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
FIRST AID DIRECT COLD-EEZE COLD REMEDY
zinc gluconate lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42961-105 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] Inactive Ingredients Ingredient Name Strength CORN SYRUP (UNII: 9G5L16BK6N) GLYCINE (UNII: TE7660XO1C) SUCROSE (UNII: C151H8M554) CHERRY (UNII: BUC5I9595W) Product Characteristics Color white (Semi-Translucent) Score no score Shape OVAL Size 23mm Flavor CHERRY Imprint Code P Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42961-105-02 20 in 1 PACKAGE 07/20/2023 1 NDC:42961-105-01 1 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/20/2023 Labeler - Cintas Corporation (056481716) Establishment Name Address ID/FEI Business Operations Pharmaloz Manufacturing, Inc. 067101998 manufacture(42961-105)