N - TIME (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]

N - TIME (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]
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NDC 68210-1500-4, 68210-1500-5, 68210-1500-6, 68210-1500-8
Set ID 390a0c89-a640-4a0b-aaf3-955b502fb33a
Category HUMAN OTC DRUG LABEL
Packager SPIRIT PHARMACEUTICALS,LLC
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients (in each LiquiCap) Purpose
    Acetaminophen 325mg Pain reliever/Fever Reducer
    Dextromethorphan Hbr 15 Cough Suppressant
    Doxylamine succinate 6.25mg Antihistamine
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  • Uses

    temporarily relieves common cold/flu symptoms:

    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches and pains
    • fever
    • runny nose and sneezing
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  • Warnings

    Alcohol Warnings :if you consume 3 or more alcoholic drinks every day, ask you doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

    Sore throat warning: If sore throat is severe, persists for more than two days, is accompanied or followed by fever,headache,rash,nausea or vomiting, consult a doctor promptly.

    Do not use

    • with other medicines containing acetaminophen
    • if you are now taking a prescription monoamine oxidase inhibitor(MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • Glaucoma
    • thyroid disease
    • trouble urinating due to enlarged postage gland
    • cough that occurs with too much phlegm(mucus)
    • A breathing problem or chronic, cough that lasts or as occurs with smoking,asthma,chronic,bronchitis or emphysema

    Ask a doctor or pharmacists before use if you are taking sedatives or tranquilizers.

    when using this product

    • do not use more than directed
    • excitability may occur,especially in children
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery
    • alcohol, sedatives and tranquilizers may increase drowsiness

    Stop use and ask doctor if

    • pain or cough gets worse or lasts more than 7 days
    • fever gets worse or less tan 3 days
    • redness or swelling is present
    • new symptoms occur
    • cough comes back or occurs with rash or headache that lasts.

    These could be signs of a serious conditions

    If pregnant or breast-feeding, ask a health professional before use

    Keep out of reach of children.

    Overdose Warning : Taking more than the recommended dose can cause serious health problems. In case of overdose,get medical help or contact a poison control center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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  • Direction

    • take only as recommended – see Overdose warning
    • do not exceed 6 doses per 24 Hours
    adults and children 12 years of age and older -2 liquicaps with water every 6 hours
    children under 12 years of age - ask a doctor
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  • Other information

    • each tablet contains : Store at room temperature
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  • Inactive ingredients

    FD &C Green No 3 IH, Polyethylene Glycol 400, Gelatin, Glycerin, Povidone, Purified water, Sorbitol

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  • PRINCIPAL DISPLAY PANEL - 6000 Softgel Label

    N-Time Soft Gelatin Capsules

    Each Soft gelatin capsule contains :
    Acetaminophen USP                              325 mg
    Dextromethorphan Hydrobromide USP   15 mg
    Doxylamine Succinate USP                  6.25 mg

    LOT NO : NDC NO : 68210-1500-6
    MFG DATE : QUANTITY : 1000 X 6 Softgels
    EXP DATE : GROSS WT. :

    WARNING:
    KEEP OUT OF REACH OF CHILDREN

    STORE AT CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
    PROTECT FROM LIGHT, MOISTURE AND FREEZING

    THIS BULK SHIPMENT IS INTENDED FOR FURTHER PACKAGING PROCESS ONLY.
    CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT
    CONFORMANCE WITH THE FD & C ACT AND REGULATIONS THEREUNDER.

    MANUFACTURED BY:
    Marksans Pharma Ltd
    VERNA, GOA-403722,
    INDIA.
    CODE : GO/DRUGS/515

    MANUFACTURED FOR:
    SPIRIT PHARMACEUTICALS LLC
    225 LINCOLN HWY, STE 205
    FAIRLESS HILLS, PA 19030
    PH.# 215 943 4000
    FAX.# 215 943 4039

    CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

    Principal Display Panel - 6000 Softgel Label
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  • INGREDIENTS AND APPEARANCE
    N - TIME 
    acetaminophen, doxylamine succinate, and dextromethorphan hydrobromide capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-1500
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg
    Inactive Ingredients
    Ingredient Name Strength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GELATIN (UNII: 2G86QN327L)  
    POVIDONE (UNII: FZ989GH94E)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Product Characteristics
    Color GREEN Score no score
    Shape OVAL Size 18mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68210-1500-5 1 in 1 DRUM
    1 5000 in 1 BAG
    2 NDC:68210-1500-6 1 in 1 DRUM
    2 6000 in 1 BAG
    3 NDC:68210-1500-4 1 in 1 DRUM
    3 4000 in 1 BAG
    4 NDC:68210-1500-8 1 in 1 DRUM
    4 8000 in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 05/30/2010
    Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)
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