Label: COLD AND FLU SEVERE DAYTIME- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 5, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each softgel)Purposes
    Acetaminophen 325 mgPain reliever/fever reducer
    Dextromethorphan HBr 10 mgCough suppressant
    Guaifenesin 200 mgExpectorant
    Phenylephrine HCl 5 mgNasal decongestant
  • Uses

    • temporarily relieves common cold/flu symptoms:
      • nasal congestion
      • sinus congestion & pressure
      • cough due to minor throat & bronchial irritation
      • minor aches & pains
      • headache
      • fever
      • sore throat
    • reduces swelling of nasal passages
    • temporarily restores freer breathing through the nose
    • promotes nasal and/or sinus drainage
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • Warnings

    Liver warning

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

    • more than 8 softgels 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

    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.

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • trouble urinating due to enlarged prostate gland
    • a sodium-restricted diet
    • 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; taking sedatives or tranquilizers.

    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.

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

    Keep out of reach of children.

    Overdose warning

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • take only as directed
    • do not exceed 8 softgels per 24 hrs
    adults & children 12 yrs & over2 softgels with water every 4 hours
    children 4 to under 12 yrsask a doctor
    children under 4 yrsdo not use
  • Other information

    • store at 20-25°C (68-77°F)
    • protect from light, heat and moisture
  • Inactive ingredients

    FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone K30, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

  • Questions?

    Call toll free: 1-888-423-0139

  • PRINCIPAL DISPLAY PANEL - 24 Softgel Blister Pack Carton

    NDC: 36800-826-24

    *Compare to the active ingredients
    in Vicks® Dayquil™ Severe Cold & Flu

    MULTI-SYMPTOM RELIEF

    Day Time
    Cold & Flu Relief
    SEVERE

    PAIN RELIEVER-FEVER REDUCER - ACETAMINOPHEN
    COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr
    EXPECTORANT - GUAIFENESIN
    NASAL DECONGESTANT - PHENYLEPHRINE HCl

    • Headache, Fever, Sore Throat, Minor Aches & Pains
    • Sinus Congestion & Pressure
    • Nasal Congestion • Cough

    Alcohol Free
    Antihistamine Free
    Non-Drowsy

    24 SOFTGELS

    actual size

    PRINCIPAL DISPLAY PANEL - 24 Softgel Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    COLD AND FLU SEVERE DAYTIME 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-986
    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
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C Yellow no. 6 (UNII: H77VEI93A8)  
    Gelatin, unspecified (UNII: 2G86QN327L)  
    Glycerin (UNII: PDC6A3C0OX)  
    Polyethylene Glycol, unspecified (UNII: 3WJQ0SDW1A)  
    Povidone K30 (UNII: U725QWY32X)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Sorbitol (UNII: 506T60A25R)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code 782
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-986-242 in 1 CARTON05/01/2021
    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 FINALpart34105/01/2021
    Labeler - TOPCO ASSOCIATES LLC (006935977)