Label: MAXIMUM STRENGTH COLD AND FLU- acetaminophen,dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule, liquid filled

  • NDC Code(s): 55319-628-16
  • Packager: FAMILY DOLLAR SERVICES
  • 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 July 14, 2021

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

  • ACTIVE INGREDIENT

    Active ingredients (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10mg

    Guaifenesin 200 mg

    Phenylephrine HCl 5 mg

  • PURPOSE

    Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Expectorant
    Nasal decongestant

  • INDICATIONS & USAGE

    • temporarily relieves these common cold and flu symptoms:

    nasal congestion

    headache

    cough

    minor aches and pains

    sore throat

    • temporarily reduces fever
    • 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
    • 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

    • 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

    • liver disease
    • heart disease
    • diabetes
    • high blood pressure
    • thyroid disease
    • trouble urinating due to 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

    taking the blood thinning drug warfarin.

  • WHEN USING

    do not use more than directed.

  • KEEP OUT OF REACH OF CHILDREN

    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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • OVERDOSAGE

    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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • STOP USE

    • 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.
  • DOSAGE & ADMINISTRATION

    Directions

    • Do not take more than directed (see Overdose warning)
    • do not exceed more than 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 at 20-25°C (68-77°F)
    • avoid excessive heat
  • INACTIVE INGREDIENT

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

  • PRINCIPAL DISPLAY PANEL

    628T-Family Dollar

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH COLD AND FLU 
    acetaminophen,dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-628
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SHELLAC (UNII: 46N107B71O)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code 78
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-628-1616 in 1 BLISTER PACK; Type 0: Not a Combination Product08/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/24/2020
    Labeler - FAMILY DOLLAR SERVICES (024472631)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LTD925822975manufacture(55319-628)