Label: MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME- acetaminophen 325 mg dextromethorphan hbr 10 mg phenylephrine hci 5 mg capsule, liquid filled

  • NDC Code(s): 11822-1989-0, 11822-1989-9
  • Packager: RITE AID
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 17, 2024

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

  • DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredients (in each softgel)
    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg
    Phenylephrine HCl 5 mg

  • PURPOSE

    Purpose
    Pain reliever/Fever reducer
    Cough suppressant
    Nasal decongestant

  • INDICATIONS & USAGE

    Uses
    temporarily relieves common cold/flu symptoms:

    • nasal congestion
    • cough due to minor throat & bronchial irritation
    • sore throat
    • headache
    • minor aches & pains
    • fever
  • WARNINGS

    Warnings

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

    • more than 8 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

    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
    • 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, or emphysema
  • 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

    • you get nervous, dizzy or sleepless
    • pain, nasal congestion or cough get worse or last 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.

  • 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. In case of overdose, get medical help or contact a Poison Control Center right away.
    Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions

    • take only as directed
    • do not exceed 4 doses per 24 hours

    adults & children 12 yrs & over: 2 softgels with water every 4 hrs
    children 4 to under 12 yrs:ask a doctor
    children under 4 yrs:do not use

  • OTHER INFORMATION

    Other information

    • store at room temperature
  • INACTIVE INGREDIENT

    Inactive ingredients FD&C red#40, FD&C yellow#6, gelatin, glycerin,polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

  • QUESTIONS

    Questions? call 1-877-290-4008

  • PRINCIPAL DISPLAY PANEL

    daytime-cold-flu-48s-ifcdaytime-24s-carton

  • INGREDIENTS AND APPEARANCE
    MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME 
    acetaminophen 325 mg dextromethorphan hbr 10 mg phenylephrine hci 5 mg capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-1989
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVAL (OBLONG SHAPED) Size21mm
    FlavorImprint Code 70
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-1989-02 in 1 CARTON09/15/2021
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:11822-1989-94 in 1 CARTON09/15/2021
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/15/2021
    Labeler - RITE AID (014578892)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(11822-1989)