Label: D - TIME- acetaminophen, phenylephrine hydrochloride, and dextromethorphan hydrobromide capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 26, 2010

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each LiquiCap)Purpose
    Acetaminophen 325mgPain reliever/Fever Reducer
    Dextromethorphan Hbr 10mgCough Suppressant
    Phenylephrine HCl 5 mgNasal 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

  • QUESTIONS

  • PRINCIPAL DISPLAY PANEL - 6000 Capsules Label

    D-Time Soft Gelatin Capsules

    Each soft gelatin capsule contains :
    Acetaminophen USP325 mg
    Phenylephrine Hydrochloride USP5 mg
    Dextromethorphan Hydrobromide USP10 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
  • SPL UNCLASSIFIED SECTION

  • INGREDIENTS AND APPEARANCE
    D - TIME 
    acetaminophen, phenylephrine hydrochloride, and dextromethorphan hydrobromide capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-1490
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorORANGEScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-1490-51 in 1 DRUM
    15000 in 1 BAG
    2NDC:68210-1490-61 in 1 DRUM
    26000 in 1 BAG
    3NDC:68210-1490-41 in 1 DRUM
    34000 in 1 BAG
    4NDC:68210-1490-81 in 1 DRUM
    48000 in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34105/30/2010
    Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)