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 August 17, 2020

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

  • DAY SEVERE COLD AND FLU

    DAY SEVERE COLD AND FLU

  • ACTIVE INGREDIENT

    DAY -EACH SOFTGEL CONTAINS

    ACETAMINOPHEN 325MG

    D0EXTROMETHORHAN HBR10 MG,

    GUAIFENESIN 200 MG

    PHENYLEPHRINE HCL 5 MG

  • INACTIVE INGREDIENT

    FD&C Blue No.1,FD&C Red No. 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac,sorbitol sorbitan solution, titanium dioxide

  • PURPOSE

    PAIN RELIEVER-FEVER REDUCER

    COUGH SUPPRESENT

    EXPECTORANT

    NASAL DECONGESTANT

  • INDICATIONS & USAGE

    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.
  • 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

  • WARNINGS

    Warnings
    Liver warning - This product contains acetaminophen. Severe liver damage may occur if you take - more than 8sogtgels

    This product contains acetaminophen.

    Severe liver damage may occur if you take

    more than 8 LiquiCaps 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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    Overdose warning

    In case of overdose, get medical help or contact a Poison Control Center right away. (1800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • NIGHT SEVERE COLD AND FLU

    NIGHT SEVERE COLD AND FLU

  • ACTIVE INGREDIENT

    (in each softgel)

    • Acetaminophen 325mg
    • Dextromethorphan HBR 10 mg
    • Doxylamine Succinate 6.25 mg
    • PhenylephrineHCl 5 mg
  • INACTIVE INGREDIENT

    FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

  • PURPOSE

    Purpose;

    Minor Aches & Pains
    Nasal/Sinus Congestion
    & Sinus Pressure
    Sneezing, Runny Nose
    Cough

  • INDICATIONS & USAGE

    Pain reliever/Fever reducer
    Cough suppressant
    Antihistamine
    Nasal decongestant

  • DOSAGE & ADMINISTRATION

    Directions
    take only as directed - do not exceed 8 softgels per 24 hours -

    • adults & children 12 yrs & over 2 softgels with water every 6 hrs -
    • children 4 to under 12 yrs ask a doctor -
    • children under 4 yrs do not use
  • WARNINGS

    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 ...

    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 ...

    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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    Overdose warning

    In case of overdose, get medical help or contact a Poison Control Center right away. (1800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • PRINCIPAL DISPLAY PANEL

    24 COMBO

  • 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
    Part 21 BLISTER PACK 16 
    Part 1 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
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    POVIDONE (UNII: FZ989GH94E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    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
    Part 2 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)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SHELLAC (UNII: 46N107B71O)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    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
    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)