NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE 325 MG, 15 MG AND 6.25 MG) CAPSULE, LIQUID FILLED [WE CARE DISTRIBUTOR INC.]

NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE 325 MG, 15 MG AND 6.25 MG) CAPSULE, LIQUID FILLED [WE CARE DISTRIBUTOR INC.]
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NDC 70005-005-02, 70005-005-25, 70005-005-50
Set ID a1964f27-6224-4a56-8f2d-3035db1f4a8b
Category HUMAN OTC DRUG LABEL
Packager We Care Distributor Inc.
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

     
     Active Ingredient (in each softgel) Purpose
     Acetaminophen 325 mg Pain reliever/fever reducer
     Dextromethorphan HBr 15 mg

    Cough suppressant

    Doxylamine succinate 6.25 mg

    Antihistamine

     

  • Uses

    Temporarily relieves common cold/flu symptoms:

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

    Liver warning:

    This product contains acetaminophen. The maximum daily dose of this product is 8 softgels (2,600 mg acetaminophen) in 24 hours. 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.
    • to make a child sleepy
    • 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
    • gloucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • 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 sedative or tranquilizers
    • taking the blood thinning drug warfarin

    When using this product

    • excitability may occur, especially in children
    • be careful when driving a motor vehicle or operating machinery
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • may cause marked drowsiness

    Stop use and ask a doctor if

    • pain 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 8 softgels per 24 hours

    • adults and children 12 years and over: 2 softgels with water every 6 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

    D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, methylparaben, polyethylene glycol, povidone, propylene glycol, propylparaben, purified water, sorbitol special, 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

    NyQuil® LiquiCaps®


    Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate 325 mg, 15 mg and 6.25 mg

    TO OPEN
    PUSH IN TAB AND PULL OUT

    25 Pouches of 2 Softgels Each

    Principal Display Panel - 50 Pouch Box

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME COLD AND FLU 
    acetaminophen, dextromethorphan hbr and doxylamine succinate 325 mg, 15 mg and 6.25 mg capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-005
    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 HYDROBROMIDE15 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    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
    ColorgreenScoreno score
    ShapeOVALSize22mm
    FlavorImprint Code SN;3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70005-005-2525 in 1 BOX
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:70005-005-5050 in 1 BOX
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:70005-005-022 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 finalpart34102/17/2016
    Labeler - We Care Distributor Inc. (079832998)
    Establishment
    NameAddressID/FEIBusiness Operations
    Softech Pharma Pvt. Ltd677111277manufacture(70005-005)

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