Label: FAST DISSOLVING DAYTIME - NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hbr,guaienesin, phenylephrine hcl,doxylamine succinate kit

  • 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 18, 2020

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  • MAXIMUM STRENGTH DAYTIME COLD AND FLU DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredients (in each softgel)

    ACETAMINOPHEN 325MG

    DEXTROMETHORHAN HBR10 MG,

    GUAIFENESIN 200 MG

    , PHENYLEPHRINE HCL 5 MG

  • INDICATIONS & USAGE

    • temporarily relieves common cold/flu symptoms: nasal congestion,headache, cough, minor aches and pains, sore throat
    • temoporarily reducces fever
    • prootes nasal and/or sinus drainage
    • helps ollsen 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 8sogtgels

    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.

  • INACTIVE INGREDIENT

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

  • DOSAGE & ADMINISTRATION

    Do not take more than directed (See Overdose warning section) - do not exceed 12 Softgels per 24 hr period

    • adults & children 12 yrs & over 2 Softgels every 4 hrs
    • children 4 to under 12 yrs: Do not 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. (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.

  • PURPOSE

    PAIN RELIEVER-FEVER REDUCER

    COUGH SUPPRESENT

    MINOR ACHES AND PAINS

    CHEST CONGESTION

  • Maximum Strength Nighttime Cold and Flu Drug Facts

  • ACTIVE INGREDIENT


    (in each softgel)
    Acetaminophen 325mg

    Dextromethorphan HBR 10 mg

    Doxylamine Succinate 6.25 mg

    PhenylephrineHCl 5mg

  • INDICATIONS & USAGE

    Purpose

    • Pain reliever/Fever reducer
    • Cough suppressant
    • Antihistamine
    • Nasal decongestant

    MINOR ACHES AND PAINS, FEVER

    NASAL CONGESTION AND SINUS PRESSURE

    SNEEZING, RUNNY NOSE

    COUGH

  • PURPOSE

    PAIN RELIEVER-FEVER REDUCER

    COUGH SUPPRESENT

    MINOR ACHES AND PAINS

    NASAL DECONGESTION

  • 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.

  • 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

  • INACTIVE INGREDIENT

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

  • 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 (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

  • PRINCIPAL DISPLAY PANEL

    24 COUNT

  • INGREDIENTS AND APPEARANCE
    FAST DISSOLVING DAYTIME - NIGHTTIME COLD AND FLU 
    acetaminophen, dextromethorphan hbr,guaienesin, phenylephrine hcl,doxylamine succinate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-7859
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-7859-024 in 1 CARTON08/18/2020
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 16 
    Part 21 BLISTER PACK 8 
    Part 1 of 2
    DAY COLD AND FLU FAST DISSOLVING 
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule, liquid filled
    Product Information
    Item Code (Source)NDC:11822-3685
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    SHELLAC (UNII: 46N107B71O)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULESize10mm
    FlavorImprint Code 78
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    116 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/18/2020
    Part 2 of 2
    NIGHT COLD AND FLU FAST DISSOLVING 
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl capsule, liquid filled
    Product Information
    Item Code (Source)NDC:11822-3684
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN (UNII: 2G86QN327L)  
    SHELLAC (UNII: 46N107B71O)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeCAPSULESize24mm
    FlavorImprint Code 72
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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 finalpart34107/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/07/2020
    Labeler - RITE AID (014578892)
    Registrant - TIME CAP LABS INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LTD925822975manufacture(11822-7859)
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