Label: DAY MAXIMUM STRENGTH COLD AND FLU RELIEF- day -acetaminophen, dextromethorhan hbr, phenylephrine hcl kit

  • NDC Code(s): 11822-3855-9, 11822-3856-8, 11822-8557-0
  • 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 18, 2020

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

  • DRUG FACTS DAY MAXIMUM STRENGTH COLD AND FLU RELIEF

    DAY MAXIMUM STRENGTH COLD AND FLU RELIEF

  • ACTIVE INGREDIENT

    Active ingredients (in each SOFTGEL)

    • Acetaminophen 325 mg
    • Dextromethorphan hydrobromide 10 mg
    • Phenylephrine hydrochloride 5 mg
  • 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

  • PURPOSE

    Purpose

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

    temporarily relieves these symptoms due to a cold or flu:

    minor aches and pains · headache · cough

    · sore throat · nasal and sinus congestion

    temporarily reduces fever

  • DOSAGE & ADMINISTRATION

    Directions:· do not take more than the recommended dose

    · adults and children 12 years and over: take 2 softgels with water

    every 4 hours.

    Do not exceed 10 softgels in 24 hours or as directed by a doctor.

    · children under 12 years: do not 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.

  • WARNINGS

    Warnings

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

    · more than 4,000 mg of acetaminophen in 24 hours

    · with other drugs containing acetaminophen

    · 3 or more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause severe skin or severe

    allergic reactions. Symptoms may include:

    · skin reddening · blisters · rash · hives

    · facial swelling · asthma (wheezing) · shock

    If a skin or general allergic 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

  • DRUG FACTS - NIGHT MAXIMUM STRENGTH COLD AND FLU RELIEF

    NIGHT MAXIMUM STRENGTH COLD AND FLU RELIEF

  • ACTIVE INGREDIENT

    Active ingredients in each softgel

    • Acetaminophen 325 mg
    • Dextromethorphan Hydrobromide 10mg
    • Doxylamine Succinate 6.25 mg
    • Phenylephrine HCl 5 mg
  • INACTIVE INGREDIENT

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

  • PURPOSE

    ACETAMINOPHEN/Pain Reliever-Fever Reducer

    Dextromethorphan Hydrobromide/Cough Suppressant

    Doxylamine Succinate/Antihistamine

    Phenylephrine HCl/Nasal Decongestant

  • INDICATIONS & USAGE

    temporarily relieves these symptoms due to a cold or flu:

    • minor aches and pains, headache, nasal and sinus congestion, cough, sore throat, runny nose, sneezing

    temporarily reduces fever

  • DOSAGE FORMS & STRENGTHS

    Directions:· do not take more than the recommended dose

    · adults and children 12 years and over: take 2 softgels water every 4 hours. Do not exceed 10 softgels in 24 hours or as

    directed by a doctor.

    · children under 12 years: do not 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.

  • WARNINGS

    Warnings

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

    · more than 4,000 mg of acetaminophen in 24 hours

    · with other drugs containing acetaminophen

    · 3 or more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause severe skin or severe

    allergic reactions. Symptoms may include:

    · skin reddening · blisters · rash · hives

    · facial swelling · asthma (wheezing) · shock

    If a skin or general allergic 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.

  • PRINCIPAL DISPLAY PANEL

    24 count

  • INGREDIENTS AND APPEARANCE
    DAY MAXIMUM STRENGTH COLD AND FLU RELIEF 
    day -acetaminophen, dextromethorhan hbr, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-8557
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-8557-01 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 MAXIMUM STRENGTH COLD AND FLU RELIEF 
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl, capsule, liquid filled
    Product Information
    Item Code (Source)NDC:11822-3856
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GELATIN (UNII: 2G86QN327L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code 72
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-3856-88 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 MAXIMUM STRENGTH COLD AND FLU RELIEF 
    day -acetaminophen, dextromethorhan hbr, phenylephrine hcl capsule, liquid filled
    Product Information
    Item Code (Source)NDC:11822-3855
    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
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POVIDONE (UNII: FZ989GH94E)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code 70
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-3855-916 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(11822-8557)