Label: DAYTIME SEVERE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, film coated

  • NDC Code(s): 68210-4231-3
  • Packager: Spirit Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 6, 2023

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

  • Drug Facts

  • Active ingredients (in each caplet)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Guaifenesin 200 mg

    Phenylephrine HCl 5

  • Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Uses

    • for the temporary relief of the following cold/flu symptoms: • minor aches and pains
    • headache • sore throat • nasal congestion • cough • helps loosen phlegm (mucus) and thin
    bronchial secretions to make coughs more productive • temporarily reduces fever

  • Warnings

    Liver warning: This product contains acetaminophen. The maximum daily dose of this product is
    10 caplets (3,250 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

    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. • 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 • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema • cough that occurs with too much phlegm (mucus)

  • Ask a doctor or pharmacist before use

    if you are taking the blood thinning drug warfarin

  • When using this product do not exceed recommended dosage

  • Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur • 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.

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    do not take more than directed

     adults and children 12 years & over • take 2 caplets every 4 hours • swallow whole; do not crush, chew or dissolve • do not take more than 10 caplets in 24 hours
     children under 12 years ask a doctor

  • Other information

    store at 25ºC (77ºF); excursions permitted between 15º–30ºC (59º–86ºF)

  • Inactive Ingredients

    croscarmellose sodium, D&C Yellow#10, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone*, pregelatinized starch, talc, titanium dioxide *may contain this ingredient

  • Questions or comments?

    1-888-333-9792

  • Distributed by:

    Cabinet Health P.B.C.

  • Principal Display panel

    Carton BackCarton Front

  • INGREDIENTS AND APPEARANCE
    DAYTIME SEVERE COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4231
    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) PHENYLEPHRINE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code ET32
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-4231-330 in 1 POUCH; Type 0: Not a Combination Product11/16/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01211/16/2022
    Labeler - Spirit Pharmaceuticals LLC (179621011)