DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL 325 MG, 10 MG AND 5 MG) CAPSULE, LIQUID FILLED [WE CARE DISTRIBUTOR INC.]

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  • DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL 325 MG, 10 MG AND 5 MG) CAPSULE, LIQUID FILLED [WE CARE DISTRIBUTOR INC.]

DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL 325 MG, 10 MG AND 5 MG) CAPSULE, LIQUID FILLED [WE CARE DISTRIBUTOR INC.]
PDF | XML
NDC 70005-003-02, 70005-003-25, 70005-003-50
Set ID e1712db4-ab19-4fa6-a6fa-b45490d145c3
Category HUMAN OTC DRUG LABEL
Packager We Care Distributor Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

     
     Active Ingredient (in each softgel) Purpose
     Acetaminophen 325 mg Pain reliever/fever reducer
     Dextromethorphan HBr 10 mg

    Cough suppressant

    Phenylephrine HCl 5 mg

    Nasal decongestant

     

  • Uses

    Temporarily relieves common cold/flu symptoms:

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

    Liver warning:

    This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Sore throat warning:

    If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
    • if you are now taking a prescription monomine 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
    • if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • thyroid disease
    • diabetes
    • high blood pressure
    • persistent or chronic cough as occurs with smoking, asthma, or emphysema
    • trouble urinating due to an enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin

    When using this product

    do not use more than directed

    Stop use and ask a doctor if

    • you get nervous, dizzy or sleepless
    • pain, nasal congestion or cough gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is present
    • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

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

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • take only as directed - see Liver warning

    • do not exceed 6 doses per 24 hours

    • adults and children 12 years and over: 2 softgels with water every 4 hours

    • children 4 to under 12 years: ask a doctor

    • children under 4 years: do not use

    • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

  • Other information

    • store at 20º-25ºC (68º-77ºF)

    • read all product information before using. Keep this box for important information
  • Inactive ingredients

    FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, methylparaben, polyethylene glycol, povidone, propylene glycol, propylparaben, purified water, sorbitol solution, titanium dioxide

  • Questions or comments?

    1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

  • PRINCIPAL DISPLAY PANEL

    See New Warnings Information & Directions

    Compare to the Active Ingredients in

    DayQuil® LiquiCaps®

    Acetaminophen, Dextromethorphan HBr and Phenylephrine HCl 325 mg, 10 mg and 5 mg

    TO OPEN
    PUSH IN TAB AND PULL OUT

    25 Pouches of 2 Softgels Each

    Principal Display Panel - 50 Pouch Box

  • INGREDIENTS AND APPEARANCE
    DAYTIME COLD AND FLU 
    acetaminophen, dextromethorphan hbr and phenylephrine hcl 325 mg, 10 mg and 5 mg capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize22mm
    FlavorImprint Code SN;2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70005-003-2525 in 1 BOX
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:70005-003-5050 in 1 BOX
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:70005-003-022 in 1 POUCH
    32 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/15/2016
    Labeler - We Care Distributor Inc. (079832998)
    Establishment
    NameAddressID/FEIBusiness Operations
    Softech Pharma Pvt. Ltd677111277manufacture(70005-003)
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