Label: ACETAMINOPHEN RAPID RELEASE- acetaminophen capsule, gelatin coated

  • NDC Code(s): 62207-167-11, 62207-167-21, 62207-167-22, 62207-167-31, view more
    62207-167-32, 62207-167-33, 62207-167-35
  • Packager: Granules India Limited
  • Category: BULK INGREDIENT
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated January 27, 2023

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  • SPL UNCLASSIFIED SECTION

    ACETAMINOPHEN RAPID RELEASE GELCAPS 500 MG

    Each rapid release gelcap contains
    Acetaminophen USP 500 mg

    Batch No.:XXXNo. of Units5 x 5000 Gelcaps
    Mfg. Dt.:MMM/YYYYGross Wt.:0.00 kg
    Exp. Dt.:MMM/YYYYTare Wt.:0.00 kg
    Mfg. Lic. No.:37/RR/AP/2003/F/RNet Wt.:0.00 kg
    NDC No.XXXXX-XXX-XXBox number:000
    Storage:Store at 20 – 25C (68 – 77F); excursions permitted to 15 – 30 C (59 – 86F); Preserve in tightly closed containers.
    CautionFor Repacking only.

    Manufactured in India by:
    Granules India Limited
    Plot No. 160/A, 161/E, Gagillapur Village
    Qutbullapur Mandal, Ranga Reddy Dt – 500 043, AP.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    apap-gelcaps-31

    apap-gelcaps-35

    62207-167-11

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN  RAPID RELEASE
    acetaminophen capsule, gelatin coated
    Product Information
    Product TypeBULK INGREDIENTItem Code (Source)NDC:62207-167
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN499.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    GELATIN (UNII: 2G86QN327L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    AMMONIA (UNII: 5138Q19F1X)  
    ALCOHOL (UNII: 3K9958V90M)  
    Product Characteristics
    Colorred, blue (blue-gray) Scoreno score
    ShapeCAPSULE (banded two-part capsule) Size19mm
    FlavorImprint Code G;1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-167-215000 in 1 BOX10/29/2013
    2NDC:62207-167-2225000 in 1 BOX10/29/2013
    3NDC:62207-167-315000 in 1 POUCH10/29/2013
    4NDC:62207-167-3210000 in 1 POUCH10/29/2013
    5NDC:62207-167-3325000 in 1 POUCH10/29/2013
    6NDC:62207-167-3525000 in 1 BOX10/29/2013
    7NDC:62207-167-1139806 in 1 DRUM05/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only10/29/2013
    Labeler - Granules India Limited (915000087)
    Registrant - Granules India Limited (915000087)
    Establishment
    NameAddressID/FEIBusiness Operations
    Granules India Limited918609236manufacture(62207-167) , analysis(62207-167)
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