Label: COLD AND FLU- acetaminophen, guaifenesin, dextromethorphan hydrobromide, 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 December 1, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each softgel)Purpose
    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 12 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
    • 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 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

    Taking more than directed can cause serious health problems. 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

    • do not take more than directed - see Overdose warning
    • do not exceed 12 softgels in any 24 hour period
    • adults and children 12 years of age and over: take 2 softgels every 4 hours
    • children under 12 years of age: do not use
  • Other information

    • store between 20-25 0C (68-77 0F)
    • avoid excessive heat
  • Inactive ingredients

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

  • Questions or comments?

    1-888-309-9030

  • PRINCIPAL DISPLAY PANEL

    Compare to active ingredients in Maximum Strength MUCINEX® FAST-MAX® COLD & FLU ALL IN ONE*

    MAXIMUM STRENGTH

    Cold & Flu

    ACETAMINOPHEN/ PAIN RELIEVER/ FEVER REDUCER

    DEXTROMETHORPHAN HBr/ COUGH SUPPRESSANT

    GUAIFENESIN/ EXPECTORANT

    PHENYLEPHRINE HCL/NASAL DECONGESTANT

    DISSOLVES QUICKLY

    Temporarily Relieves headache, fever, sore throat,

    minor aches & pains, cough, chest congestion,

    nasal/sinus congestion & sinus pressure

    20 Softgels

    image description

  • INGREDIENTS AND APPEARANCE
    COLD AND FLU 
    acetaminophen, guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-862
    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
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVAL (OBLONG) Size20mm
    FlavorImprint Code 341
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-862-202 in 1 CARTON03/12/2020
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/12/2020
    Labeler - Dolgencorp, Inc. (068331990)