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D - TIME (SPIRIT PHARMACEUTICALS,LLC)

Available Formats

Dosage Form Package Information Links
CAPSULE, LIQUID FILLED 1 BAG in 1 DRUM (68210-1490-5) > 5000 CAPSULE, LIQUID FILLED in 1 BAG Label Information
CAPSULE, LIQUID FILLED 1 BAG in 1 DRUM (68210-1490-4) > 4000 CAPSULE, LIQUID FILLED in 1 BAG Label Information
CAPSULE, LIQUID FILLED 1 BAG in 1 DRUM (68210-1490-8) > 8000 CAPSULE, LIQUID FILLED in 1 BAG Label Information
CAPSULE, LIQUID FILLED 1 BAG in 1 DRUM (68210-1490-6) > 6000 CAPSULE, LIQUID FILLED in 1 BAG Label Information

Complete D - TIME Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active ingredients (in each LiquiCap) Purpose
    Acetaminophen 325mg Pain reliever/Fever Reducer
    Dextromethorphan Hbr 10mg Cough Suppressant
    Phenylephrine HCl 5 mg Nasal Decongestant

  • INDICATIONS & USAGE

    Uses

    temporarily relieves common cold/flu symptoms:

    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches and pains
    • fever
    • nasal congestion

  • 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
    • heart disease
    • thyroid disease
    • Diabetes
    • high blood pressure
    • trouble urinating due to enlarged postage gland
    • cough that occurs with too much phlegm(mucus)
    • persistent or chronic cough as occurs with smoking, asthma or emphyesma

    when using this product do not use more than directed

    Stop use and ask doctor if
    • you get nervous,dizzy or sleepless
    • symptoms get worse or last more than 5 days (children) or 7 days (adults)
    • 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.


  • 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 4 hours
    children under 12 years of age - ask a doctor

  • Other information

    • each tablet contains : Store at room temperature

  • Inactive ingredients

    FD &C Red No 40 IH, Polyethylene Glycol 400, Gelatin, Glycerin, Povidone, Purified water, Sorbitol


  • PRINCIPAL DISPLAY PANEL - 6000 Capsules Label

    D-Time Soft Gelatin Capsules

    Each soft gelatin capsule contains :
    Acetaminophen USP 325 mg
    Phenylephrine Hydrochloride USP 5 mg
    Dextromethorphan Hydrobromide USP 10 mg
    LOT NO : NDC NO : 68210-1490-6
    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"

    OGIL056

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    D - TIME 
    acetaminophen, phenylephrine hydrochloride, and dextromethorphan hydrobromide capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-1490
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 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 RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Color ORANGE Score no score
    Shape OVAL Size 18mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68210-1490-5 1 in 1 DRUM
    1 5000 in 1 BAG
    2 NDC:68210-1490-6 1 in 1 DRUM
    2 6000 in 1 BAG
    3 NDC:68210-1490-4 1 in 1 DRUM
    3 4000 in 1 BAG
    4 NDC:68210-1490-8 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)