Label: MAXIMUM STRENGTH COLD AND FLU- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl 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 November 14, 2022

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

  • ACTIVE INGREDIENT

    Active ingredients (in each softgel)

    acetamnophen 325 mg

    Dextromethorphan HBr 10mg

    Gualifenesin 200 mg

    Phenylephrine HCl 5 mg

  • PURPOSE

    Purpose

    • Pain reliever/fever reducer
    • Cough suppressant
    • Expectorant
    • Nasal decongestant
  • INDICATIONS & USAGE

    Uses

    temporarily relieves these common cold/flu symptoms:

    • nasal congestion
    • headache
    • cough
    • minor aches & 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

    Warnings
    Liver warning

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

    • more than 12 softgels in 24 hrs, which is the maximum daily amount for this product
    • 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.
    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 exceed more than 12 softgels in any 24-hour period
    • adults and children 12 years of age and older: take 2 softgels every 4 hours.
    • children under 12 years of age: do not use

  • STORAGE AND HANDLING

    Other information

    • store at 20-25°C (68-77°F)
    • avoid excessive heat
  • QUESTIONS

    Questions?

    Call 1-877-290-4008

  • INACTIVE INGREDIENT

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

  • PRINCIPAL DISPLAY PANEL

    628T-Target-Daytime-16s

  • 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:11673-978
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN (UNII: 2G86QN327L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULESize10mm
    FlavorImprint Code 78
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-978-162 in 1 CARTON06/08/2020
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/08/2020
    Labeler - TARGET CORP (006961700)
    Registrant - TIME CAP LABS INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LTD925822975manufacture(11673-978)