Scribd Logo
Upload

Welcome to Scribd!

  • 169 views

    Labeling Requirements of Drugs

    Uploaded by

    Hannah Bernardo
    The document summarizes the labeling of Ascorbic Acid Cecon 500 mg chewable tablets manufactured by Interphil Laboratories, Inc. The principal display panel and outer label conform to requirements but the side panel does not include all required contraindication, precaution, and warning statements. The inner label includes the generic and brand names, dosage form, strength, manufacture and expiry dates, and registration number as required. A package insert is not included.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOCX, PDF, TXT or read online from Scribd

    Labeling Requirements of Drugs

    Uploaded by

    Hannah Bernardo
    169 views2 pages
    The document summarizes the labeling of Ascorbic Acid Cecon 500 mg chewable tablets manufactured by Interphil Laboratories, Inc. The principal display panel and outer label conform to requirements but the side panel does not include all required contraindication, precaution, and warning statements. The inner label includes the generic and brand names, dosage form, strength, manufacture and expiry dates, and registration number as required. A package insert is not included.

    Original Description:

    Copyright

    © Attribution Non-Commercial (BY-NC)

    Available Formats

    DOCX, PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    The document summarizes the labeling of Ascorbic Acid Cecon 500 mg chewable tablets manufactured by Interphil Laboratories, Inc. The principal display panel and outer label conform to requirements but the side panel does not include all required contraindication, precaution, and warning statements. The inner label includes the generic and brand names, dosage form, strength, manufacture and expiry dates, and registration number as required. A package insert is not included.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    169 views2 pages

    Labeling Requirements of Drugs

    Uploaded by

    Hannah Bernardo
    The document summarizes the labeling of Ascorbic Acid Cecon 500 mg chewable tablets manufactured by Interphil Laboratories, Inc. The principal display panel and outer label conform to requirements but the side panel does not include all required contraindication, precaution, and warning statements. The inner label includes the generic and brand names, dosage form, strength, manufacture and expiry dates, and registration number as required. A package insert is not included.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 2

    Bernardo, Maria Rosealle L.

    PH 3-4 DRUG GENERIC NAME: BRAND NAME : DOSAGE STRENGTH : DOSAGE FORM : MANUFACTURED BY : LABEL PARTS:
    1.) Principal Display Panel

    ASCORBIC ACID CECON 500 mg/ CHEWABLE TABLET CHEWABLE TABLET INTERPHIL LABORATORIES, INC. DISPOSITION

    REMARKS: Generic Name Prominently printed in full and not abbreviated, included every time the brand name appears, enclosed by an outlined box rendered in the same color as the generic box. Brand Name Printed immediately below the generic name having the same typeface font , text color, background color but smaller font size than the generic name. Dosage Form In accordance with the acceptable dosage form in the official monograph and well specified as chewable tablet. Dosage Strength expressed in milligram (mg) Pharmacologic Category Approved pharmacologic category, in accordance as approved by the Advisory Committee for FDA. Complete name and address of manufacturer The name of the companies printed on the labeling materials are identical with the printed Certificate of Product Registration, including the street number, street name, city/town,province,country as location of the company. Net Content Contain the total amount of 15 chewable tablets per box.

    Outer Label

    Conforms

    Conforms

    Conforms Conforms

    Conforms

    Conforms

    Conforms

    Side PANEL

    Formulation Active ingredients are stated in their generic name and is expressed in unit potency as 500mg of ascorbic acid per chewable tablet. Indication Clinical use is indicated with accordance to the official reference and as indicated by the applicant company and approved by the Advisory Committee of FDA. Contraindication/s, Precaution/s and Warning/s Does not have information regarding the contraindication/s and precautions to the use of drug. Warning statements as required and specified by FDA are stated. Mode of administration/direction for use Dosage and usual dosage are indicated.

    Conforms

    Conforms

    Does not conform Conforms

    Batch/Lot number Both the immediate label and secondary label has a printed Lot number on one side of the label together with the date manufacture and expiration date. Date of Manufacture and expiry date Expressed in terms of the month and the year, printed on both immediate label and secondary label, and follows the shelf-life indicated on the CPR. Registration Number Corresponds to the drug registration number and code assigned by FDA and as reflected on the CPR of the product, both are prominently printed on the immediate label and secondary label. Storage Condition Includes a storage caution of Store at temperatures not exceeding 30OC

    Conforms Conforms

    Conforms

    COnforms

    Leaflets/ Package Insert

    -Does not have a package insert with information about contraindication/s, precaution/s and warning statement specified by FDA.

    Inner Label

    Generic Name Prominently printed in full and not abbreviated, included every time the brand name appears, enclosed by an outlined box rendered in the same color as the generic box. Brand Name Printed immediately below the generic name having the same typeface font , text color, background color but smaller font size than the generic name. Dosage Form In accordance with the acceptable dosage form in the official monograph and well specified as chewable tablet. Dosage Strength expressed in milligram (mg) Date of Manufacture and expiry date Expressed in terms of the month and the year, printed on both immediate label and secondary label, and follows the shelf-life indicated on the CPR. Registration Number Corresponds to the drug registration number and code assigned by FDA and as reflected on the CPR of the product, both are prominently printed on the immediate label and secondary label.

    You might also like