DAYTIME NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [STRIVE PHARMACEUTICALS INC.]

DAYTIME NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [STRIVE PHARMACEUTICALS INC.]
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NDC 70692-602-12
Set ID 7a027fdf-a69a-9cbf-e053-2a91aa0ac4d6
Category HUMAN OTC DRUG LABEL
Packager Strive Pharmaceuticals Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist, Antihistamine
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active ingredients (in each Softgel) (Daytime)Purpose
    Acetaminophen 325mgPain Reliever/fever reducer
    Dextromethorphan HBr 10mgCough suppressant
    Phenylephrine HCl 5mgNasal Decongestant
    Active ingredients (in each Softgel) (Nighttime)Purpose
    Acetaminophen 325mgPain Reliever/fever reducer
    Dextromethorphan HBr 15mgCough suppressant
    Docylamine Succinate 6.25mgAntihistamine

  • PURPOSE

    Daytime

    Pain reliever/fever reducer, Cough suppresant and Nasal decongestant

    Nighttime

    Pain reliever/fever reducer, Cough suppressant and Antihistamine

  • INDICATIONS & USAGE

    * temporarily relieves common cold/flu symptoms:

    • nasal congestion (Daytime only)
    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches and pains
    • fever
    • runny nose and sneezing (Nighttime only)

  • WARNINGS

    Liver warning:
    This product contains acetaminophen. Severe liver damage may occur if you take:
    *more than 4 doses in 24 hrs, which is the maximum daily amount for this product
    * with other drugs containing acetaminophen
    *3 or more alcoholic drinks every day while using this product

    Allergy alert:
    Acetaminophen may cause severe skin reactions. Symptoms may include:
    *skin reddening
    *blisters
    *rash
    If a skin reaction occurs, stop use and seek medical help right away.

    Sore throat warning:

    if sore throat is severe, persists for more than 2 days, is accompanied or 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 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.

    *to make a child sleep (Nighttime only).

    Ask a doctor before use if you have

    * liver disease
    * heart disease (Daytime only)
    * high blood pressure (Daytime only)
    * thyroid disease (Daytime only)
    * trouble urinating due to an enlarged prostate gland
    * glaucoma (Nighttime only)
    * persistent or chronic cough such as occurs with smoking, asthma or emphysema and (Nighttime only) chronic bronchitis
    * cough that occurs with too much phlegm (mucus)

    Ask a doctor or a pharmacist before use if you are
    * taking the blood thinning drug warfarin
    * taking sedatives or tranquilizers (Nighttime only)

    When using this product
    Do not use more than directed. In addition when using Nighttime:
    * excitability may occur, especially in children
    * marked drowsiness may occur
    * alcohol, sedatives, and tranquilizers may increase drowsiness
    * be careful when driving a motor vehicle or operating machinery
    * avoid alcoholic drinks

    Stop use and ask a doctor if
    * you get nervous, dizzy, or sleepless (Daytime only)
    * pain, cough and nasal congestion (Daytime only) may get worse or lasts more than 7 days
    * new symptoms occur
    * fever gets worse or lasts more than 3 days
    * 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 care professional before use.

    Keep out of reach of children

    OVERDOSE WARNING:
    Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children
    OVERDOSE WARNING:

    Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions
    * take only as directed - see OVERDOSE WARNING

    * do not exceed 4 doses per 24 hrs
    * take softgels with water

    Read each label carefully before taking Daytime and Nighttime product

    DaytimeNighttime
    adulta & children age 12 years & over2 softgels every 4 hours2 softgels every 6 hours
    children 4 to under 12 yearsask a doctorask a doctor
    children under 4 yearsdo not usedo not use

  • OTHER SAFETY INFORMATION

    Other information
    * store at room temperature between 20 - 25°C (68 - 77°F)

    *avoid excessive heat, cold and humidity

  • INACTIVE INGREDIENT

    Inactive ingredients (Daytime)
    FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.


    Inactive ingredients (Nightime)
    D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.

  • PRINCIPAL DISPLAY PANEL

    Daytime Nighttime Cold & Flu

  • INGREDIENTS AND APPEARANCE
    DAYTIME NIGHTTIME COLD AND FLU 
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70692-602
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70692-602-121 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product11/06/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK
    Part 21 BLISTER PACK
    Part 1 of 2
    DAYTIME NIGHTTIME COLD AND FLU 
    acetaminophen, dextromethorphan hbr , phenylephrine hcl capsule, liquid filled
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorredScoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code 604
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/06/2018
    Part 2 of 2
    DAYTIME NIGHTTIME COLD AND FLU 
    acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code 603
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/06/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/06/2018
    Labeler - Strive Pharmaceuticals Inc. (080028013)

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