Label: CORICIDIN HBP COLD AND FLU- acetaminophen and chlorpheniramine maleate tablet, film coated

  • NDC Code(s): 11523-4325-1, 11523-4325-2
  • Packager: Bayer HealthCare LLC.
  • 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 March 24, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients
    (in each tablet)    		Purpose
    Acetaminophen 325 mgPain reliever/ fever reducer
    Chlorpheniramine maleate 2 mgAntihistamine
  • Uses

    • temporarily relieves
      • minor aches and pains
      • headache
      • sneezing
      • runny nose
    • temporarily reduces fever
  • Warnings

    Liver Warning

    This product contains acetaminophen. Sever liver damage may occur if

    • adult takes more than 12 tablets in 24 hours
    • child takes more than 5 tablets in 24 hours
    • taken with other drugs containing acetaminophen
    • adult has 3 or more alcoholic drinks everyday while using this product.

    Do not use with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    Ask a doctor before use if the user has

    • liver disease
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if the user is

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

    When using this product

    • excitability may occur, especially in children
    • drowsiness may occur
    • avoid alcoholic beverages
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • use caution when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • pain gets worse or lasts more than 5 days (children 6 to under 12 years) or 10 days (adults)
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    Overdose Warning

    Taking more than the recommended dose may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

  • Directions

    Adults and children 12 years and over2 tablets every 4 to 6 hours, not more than 12 tablets in 24 hours
    Children 6 to under 12 years of age1 tablet every 4 to 6 hours, not more than 5 tablets in 24 hours
    Children under 6 years of ageask a doctor
  • Other information

    • store between 20° to 25°C (68° to 77°F)
  • Inactive ingredients

    corn starch, FD&C red No. 40 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide

  • Questions or comments?

    Call 1-800-317-2165

  • PRINCIPAL DISPLAY PANEL - 10 Tablet Carton

    Coricidin ®

    HBP

    Decongestant-free

    COLD SYMPTOM RELIEF for people with

    HIGH BLOOD PRESSURE

    Chlorpheniramine - Antihistamine,

    Acetaminophen - Pain Reliever/Fever Reducer

    See New Warnings Information

    COLD

    & FLU

    Relieves:

    • Runny Nose
    • Sneezing
    • Body Aches
      and Pains
    • Fever

    10 TABLETS NDC 11523-4325 (002).jpg

  • INGREDIENTS AND APPEARANCE
    CORICIDIN HBP  COLD AND FLU
    acetaminophen and chlorpheniramine maleate tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-4325
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code CF
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-4325-11 in 1 CARTON10/01/2013
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:11523-4325-22 in 1 CARTON10/01/2013
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/01/2013
    Labeler - Bayer HealthCare LLC. (112117283)
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