SINEX (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [THE PROCTER & GAMBLE MANUFACTURING COMPANY]

SINEX (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [THE PROCTER & GAMBLE MANUFACTURING COMPANY]
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NDC 37000-508-24
Set ID 3a36815b-7974-6111-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager The Procter & Gamble Manufacturing Company
Generic Name
Product Class alpha-1 Adrenergic Agonist, Antihistamine
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each LiquiCap)Purpose
    Acetaminophen 325 mgPain reliever/Fever reducer
    Doxylamine succinate 6.25 mgAntihistamine
    Phenylephrine HCl 5 mgNasal decongestant
  • Uses

    • temporarily relieves symptoms due to the common cold
      • minor aches and pains
      • headache
      • fever
      • runny nose and sneezing
      • nasal congestion
      • sinus congestion & pressure
    • temporarily relieves symptoms due to hay fever or other upper respiratory allergies
      • minor aches and pains
      • headache
      • runny nose and sneezing
      • itching of the nose or throat, and itchy, watery eyes
      • nasal congestion
      • sinus congestion & pressure
  • Warnings

    Liver warning

    This product contains acetaminophen.

    Severe liver damage may occur if you take

    • more than 4 doses in 24 hours, 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

    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

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • thyroid disease
    • diabetes
    • high blood pressure
    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due to enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    • taking sedatives or tranquilizers
    • taking the blood thinning drug warfarin

    When using this product

    • do not use more than directed
    • excitability may occur, especially in children
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery
    • alcohol, sedatives & tranquilizers may increase drowsiness

    Stop use and ask a doctor if

    • pain or nasal congestion gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • you get nervous, dizzy or sleepless

    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 right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

  • Directions

    • take only as directed
    • do not exceed 4 doses per 24 hrs
    adults & children 12 yrs & over2 LiquiCaps with water every 4 hrs
    children 4 to under 12 yrsask a doctor
    children under 4 yrsdo not use
  • Other information

    • store at room temperature
  • Inactive ingredients

    FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

  • Questions or comments?

    1-800-873-8276

  • SPL UNCLASSIFIED SECTION

    DIST. BY PROCTER & GAMBLE,
    CINCINNATI, OH 45202.

  • PRINCIPAL DISPLAY PANEL - 24 Liquicap Blister Pack Carton

    FAST

    RELIEF

    VICKS®

    Sinex

    NIGHTTIME
    CONGESTION, PRESSURE & PAIN

    Acetaminophen-Pain Reliever,

    Phenylephrine HCl-Nasal Decongestant,

    Doxylamine succinate-Antihistamine

    MAX
    STRENGTH

    • Sinus Congestion & Pressure
    • Pain & Headache
    • Runny Nose

    24 LIQUICAPS

    508 Carton

  • INGREDIENTS AND APPEARANCE
    SINEX 
    acetaminophen, doxylamine succinate, and phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-508
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorturquoiseScoreno score
    ShapeOVALSize21mm
    FlavorImprint Code VS;NIGHT
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-508-2412 in 1 CARTON07/29/2016
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/29/2016
    Labeler - The Procter & Gamble Manufacturing Company (004238200)