Label: VITAMIN C DROPS- vitamin c tablet, chewable, extended release

  • NDC Code(s): 80404-601-01, 80404-601-02, 80404-601-03, 80404-601-04
  • Packager: Xinsanyang Pharmaceutical (Xiamen) Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated July 4, 2023

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  • SPL UNCLASSIFIED SECTION

    Vitamin C Drops

  • ACTIVE INGREDIENT

    ASCORBIC ACID(Vitamin C 135mg)

  • PURPOSE

    AS A DIETARY SUPPLEMENT TAKE

  • INDICATIONS & USAGE

    SUGGESTED USE: AS A DIETARY SUPPLEMENT TAKE ONE(1)SERVING.FOR AGES 5-13. DO NOT EXCEED TWO (2) SERVINGSPER DAY FOR AGES 14 AND OVERDO NOT EXCEED SIX(6SERVINGS PER DAY IF YOU ARE PREGNANTNURSING ORTAKING ANY MEDICATIONSCONSULT YOUR DOCTOR BEFOREUSE.KEEP OUT OF REACH OF CHILDREN

  • WARNINGS

    NOT FOR CHILDREN UNDER 4.

  • DO NOT USE

    NOT FOR CHILDREN UNDER 4.

    DO NOT EXCEED TWO (2) SERVINGSPER DAY FOR AGES 14 AND OVERDO
    NOT EXCEED SIX(6)SERVINGS PER DAY
    IF YOU ARE PREGNANTNURSING ORTAKING ANY MEDICATIONSCONSULT YOUR DOCTOR BEFOREUSE.

  • WHEN USING

    SUGGESTED USE: AS A DIETARY SUPPLEMENT TAKE ONE(1)SERVING.FOR AGES 5-13.

  • STOP USE

    NOT FOR CHILDREN UNDER 4.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • DOSAGE & ADMINISTRATION

    SUGGESTED USE: AS A DIETARY SUPPLEMENT TAKE ONE(1)SERVING.FOR AGES 5-13.
    DO NOT EXCEED TWO (2) SERVINGSPER DAY FOR AGES 14 AND OVERDO
    NOT EXCEED SIX(6)SERVINGS PER DAY
    IF YOU ARE PREGNANTNURSING ORTAKING ANY MEDICATIONSCONSULT YOUR DOCTOR BEFOREUSE.

  • STORAGE AND HANDLING

    Shade and avoid direct sunlight

  • INACTIVE INGREDIENT

    BETA CAROTENE,CITRIC ACID,GLUCOSE SYRUP, FD&C RED NO. 40, SOY LECITHIN, SUCROSE, SODIUM ASCORBATE

  • PRINCIPAL DISPLAY PANEL

    label2

  • INGREDIENTS AND APPEARANCE
    VITAMIN C DROPS 
    vitamin c tablet, chewable, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80404-601
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID2.25 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    BETA CAROTENE (UNII: 01YAE03M7J)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.6 mg  in 100 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80404-601-0125 mg in 1 BAG; Type 0: Not a Combination Product07/03/2023
    2NDC:80404-601-0230 mg in 1 BAG; Type 0: Not a Combination Product07/03/2023
    3NDC:80404-601-0370 mg in 1 BAG; Type 0: Not a Combination Product07/03/2023
    4NDC:80404-601-0480 mg in 1 BAG; Type 0: Not a Combination Product07/03/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/03/2023
    Labeler - Xinsanyang Pharmaceutical (Xiamen) Co., Ltd. (546457554)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xinsanyang Pharmaceutical (Xiamen) Co., Ltd.546457554manufacture(80404-601)
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