Label: DAY-NIGHT SEVERE COLD AND FLU- day -acetaminophen, dextromethorhan hbr, guaifenesin, phenylephrine hcl night- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl, kit

  • NDC Code(s): 11822-3853-8, 11822-3854-9, 11822-8554-0
  • Packager: RITE AID
  • 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 January 5, 2022

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

  • DAYTIME COLD AND FLU

    DAY SEVERE COLD AND FLU

  • ACTIVE INGREDIENT

    Active ingredients (in each softgel)

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Guaifenesin 200 mg
    Phenylephrine HCl 5 mg

  • PURPOSE

    Purposes
    Pain reliever/fever reducer
    Cough suppressant
    Expectorant
    Nasal decongestant

  • INDICATIONS & USAGE

    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

    Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
    • more than 8 softgels in 24 hrs, 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, chronic bronchitis, 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 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.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, 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 (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

    • take only as directed
    • do not exceed 8 softgels per 24 hrs

    adults & children 12 yrs & over: 2 softgels with water every 4 hours.

    children 4 to under 12 yrs: ask a doctor

    children under 4 yrs: do not use

  • OTHER SAFETY INFORMATION

    Other information

    • do not exceed 25°C
  • INACTIVE INGREDIENT

    Inactive ingredients
    FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

  • QUESTIONS

    Questions or Comments?
    call 1-877-290-4008

  • NIGHTTIME COLD & FLU

    NIGHT SEVERE COLD AND FLU

  • ACTIVE INGREDIENT

    Active ingredients (in each softgel)
    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Doxylamine succinate 6.25 mg
    Phenylephrine HCl 5 mg

  • PURPOSE

    Purposes
    Pain reliever/fever reducer
    Cough suppressant
    Antihistamine
    Nasal decongestant

  • INDICATIONS & USAGE

    Uses

    temporarily relieves common cold/flu symptoms:
    • nasal congestion
    • sinus congestion & pressure
    • cough due to minor throat & bronchial irritation
    • cough to help you sleep
    • minor aches & pains
    • headache
    • fever
    • sore throat
    • runny nose & sneezing
    • reduces swelling of nasal passages
    • temporarily restores freer breathing through the nose
    • promotes nasal and/or sinus drainage

  • WARNINGS

    Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
    • more than 8 softgels in 24 hrs, 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
    • glaucoma
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • trouble urinating due to enlarged prostate gland

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are
    • taking sedatives or tranquilizers
    • taking the blood thinning drug warfarin

  • WHEN USING

    When using this product
    do not use more than directed
    • excitability may occur, especially in children
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery
    • alcohol, sedatives, & tranquilizers may increase drowsiness

  • STOP USE

    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.

  • 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 (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
    • take only as directed
    • do not exceed 8 softgels per 24 hrs
    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 SAFETY INFORMATION

    Other information
    • do not exceed 25°C

  • INACTIVE INGREDIENT

    Inactive ingredients
    FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

  • QUESTIONS

    Questions or Comments?
    call 1-877-290-4008

  • PRINCIPAL DISPLAY PANEL

    627T-Riteaid-Severe-Cold-Flu-carton-24s

  • INGREDIENTS AND APPEARANCE
    DAY-NIGHT SEVERE COLD AND FLU 
    day -acetaminophen, dextromethorhan hbr, guaifenesin, phenylephrine hcl night- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl, kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-8554
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-8554-01 in 1 BLISTER PACK; Type 0: Not a Combination Product08/03/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 16 
    Part 21 BLISTER PACK
    Part 1 of 2
    DAY SEVERE COLD AND FLU RELIEF 
    acetaminophen, dextromethorhan hbr, guaifenesin, phenylephrine hcl capsule, liquid filled
    Product Information
    Item Code (Source)NDC:11822-3854
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SHELLAC (UNII: 46N107B71O)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColororangeScoreno score
    ShapeBULLETSize16mm
    FlavorImprint Code 73
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-3854-916 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/03/2020
    Part 2 of 2
    NIGHT SEVERE COLD AND FLU RELIEF 
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl, capsule, liquid filled
    Product Information
    Item Code (Source)NDC:11822-3853
    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
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeBULLETSize16mm
    FlavorImprint Code 72
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-3853-88 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/03/2020
    Labeler - RITE AID (014578892)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LTD925822975manufacture(11822-8554)