Label: COLD, FLU AND SORE THROAT RELIEF- acetaminophen 650 mg, dextromethorphan hbr 20 mg, guaifenesin 400 mg, phenylephrine hcl 10 mg liquid

  • NDC Code(s): 21130-909-03
  • Packager: BETTER LIVING BRANDS, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 31, 2025

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

  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 20 mL)

    Acetaminophen 650 mg

    Dextromethorphan HBr 20 mg

    Guaifenesin 400 mg

    Phenylephrine HCl 10 mg

  • PURPOSE

    Purposes

    Pain reliever/fever reducer

    Cough suppressant

    Expectorant

    Nasal decongestant

  • INDICATIONS & USAGE

    Uses
    ■ temporarily relieves these common cold and flu
    symptoms:
    ■ cough
    ■ nasal congestion
    ■ minor aches and pains
    ■ sore throat
    ■ headache
    ■ stuffy nose
    ■ sinus congestion and pressure
    ■ temporarily reduces fever
    ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

  • WARNINGS

    Warnings


    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
    ■ more than 6 doses in 24 hours, which is the maximum daily amount
    ■ 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.


    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

    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 DOCTOR

    Ask a doctor before use if you have
    ■ liver disease
    ■ heart disease
    ■ diabetes
    ■ high blood pressure
    ■ thyroid disease
    ■ 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 DOCTOR/PHARMACIST

    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

    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 fever, 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

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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.

  • DOSAGE & ADMINISTRATION

    Directions
    do not take more than directed (see Overdose warning)
    ■ do not take more than 6 doses in any 24-hour period
    ■ measure only with dosing cup provided
    ■ do not use dosing cup with other products
    ■ dose as follows or as directed by a doctor
    ■ adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
    ■ children under 12 years of age: do not use

  • OTHER SAFETY INFORMATION

    Other information
    each 20 mL contains: sodium 15 mg
    ■ store at 20-25°C (68-77°F)
    ■ do not refrigerate

  • INACTIVE INGREDIENT

    Inactive ingredients
    anhydrous citric acid, edetate disodium, FD&C blue 1, FD&C red 40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

  • QUESTIONS

    Questions or comments?
    Call 1-877-290-4008

  • PRINCIPAL DISPLAY PANEL

    769L-Albertsons-Cold Flu Sore Throat Relief-6Oz-Front label

    IMAGE NAME	IMAGE	DELETE IMAGE	REFERENCED 769L-Albertsons-Cold Flu Sore Throat Relief-6Oz-Back label

  • INGREDIENTS AND APPEARANCE
    COLD, FLU AND SORE THROAT RELIEF 
    acetaminophen 650 mg, dextromethorphan hbr 20 mg, guaifenesin 400 mg, phenylephrine hcl 10 mg liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-909
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-909-03177 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/01/2025
    Labeler - BETTER LIVING BRANDS, LLC (009137209)
    Registrant - TIME CAP LABORATORIES, INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED677604129manufacture(21130-909)