Label: VICKS SINEX SEVERE ALL IN ONE SINUS MUCUS- acetaminophen, phenylephrine hcl, guaifenesin capsule, liquid filled

  • NDC Code(s): 37000-951-24
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 16, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each LiquiCap)

    Acetaminophen 325 mg

    Phenylephrine HCl 5 mg

    Guaifenesin 200 mg

    Purpose

    Pain reliever/fever reducer

    Nasal decongestant

    Expectorant

  • Uses

    temporarily relieves symptoms due to the common cold (or a cold)

    • minor aches and pains
    • headache
    • fever
    • nasal congestion
    • sinus congestion & pressure
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
    • temporarily relieves symptoms due to hay fever or other upper respiratory allergies
    • minor aches and pains
    • headache
    • nasal congestion
    • sinus congestion & pressure
  • Warnings

    Liver warning:

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

    • more than 8 LiquiCaps in 24 hours, which is the maximum daily amount for this product
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily 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

  • 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.
  • Ask a doctor before use if you have

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin

  • WHEN USING

    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
    • 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 condition.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    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.

  • Directions

    • take only as directed
    • do not exceed 8 LiquiCaps 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

    • do not exceed 25ºC
  • Inactive ingredients

    ammonium hydroxide, D&C Red No. 33, FD&C Red No.40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, simethicone, sorbitol sorbitan solution, titanium dioxide

  • Questions?

    1-800-362-1683

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT:This package is safely sealed & child resistant.

    Use only if blisters are intact. If difficult to open, use scissors.

  • SPL UNCLASSIFIED SECTION

    Made in Canada

    DIST. BYPROCTER & GAMBLE,
    CINCINNATI OH 45202

  • PRINCIPAL DISPLAY PANEL - 24 LiquiCap Carton

    VICKS® Sinex™ SEVERE ALL IN ONE SINUS + MUCUS

    Acetaminophen- Pain reliever/Fever Reducer,

    Phenylephrine HCl - Nasal Decongestant,

    Guaifenesin - Expectorant

    • Sinus Pressure
    • Sinus Headache & Pain
    • Sinus Congestion
    • Thins & Loosens Mucus

    NON-DROWSY

    24 LiquiCaps™

    951

  • INGREDIENTS AND APPEARANCE
    VICKS SINEX SEVERE  ALL IN ONE SINUS MUCUS
    acetaminophen, phenylephrine hcl, guaifenesin capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-951
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    SHELLAC (UNII: 46N107B71O)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    AMMONIA (UNII: 5138Q19F1X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SORBITOL (UNII: 506T60A25R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeBULLETSize16mm
    FlavorImprint Code VSSC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-951-242 in 1 CARTON07/10/2018
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/10/2018
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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