Label: CORICIDIN HBP DAY AND NIGHT- dextromethorphan hydrobromide, guaifenesin, acetaminophen, chlorpheniramine maleate kit

  • NDC Code(s): 11523-4111-1, 11523-4221-1, 11523-4765-1
  • 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 December 6, 2022

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  • SPL UNCLASSIFIED SECTION

    Coricidin HBP Day

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each softgel)Purpose
    Dextromethorphan hydrobromide 10 mgCough Suppressant
    Guaifenesin 200 mgExpectorant
  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • Warnings

    Do not use 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 a doctor before use if you have

    • cough that occurs with excessive phlegm (mucus)
    • persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Stop use and ask a doctor if cough lasts more than 7 days, reoccurs, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.

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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Abuse of this product can lead to serious injury.

  • Directions

    • do not exceed recommended dose
    • do not take the Day and Night products at the same time; wait 4 hours after the last Night dose before starting Day product
    • adults and children 12 years and over: 1 or 2 softgels every 4 hours, not more than 6 softgels in 12 hours
    • children under 12 years of age: ask a doctor
  • Other Information

    • store between 20° to 25°C (68° to 77°F)
    • protect from freezing
    • protect from excessive moisture
  • Inactive Ingredients

    FD&C blue no. 1, FD&C red no. 40, gelatin, glycerin, pharmaceutical ink, polyethylene glycol 400, povidone, propylene glycol, sorbitol

  • SPL UNCLASSIFIED SECTION

    Coricidin HBP Night

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)Purpose
    Acetaminophen 500 mgPain reliever/fever reducer
    Chlorpheniramine maleate 2 mgAntihistamine
    Dextromethorphan hydrobromide 15 mgCough Suppressant
  • Uses

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

    Liver Warning

    This product contains acetaminophen.

    Sever liver damage may occur if you take

    • more than 4 tablets in 12 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day 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.
    • 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 a MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • liver disease
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • cough that occurs with excessive phlegm (mucus)
    • a breathing problem or persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Ask a doctor or pharmacist before use if you are

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

    When using this product

    • excitability may occur, especially in children
    • marked 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 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 a rash or headache that lasts. These could be signs of a serious condition.

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

    Keep out of reach of children. Abuse of this product can lead to serious injury.

    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

    • do not use more than directed (see overdose warning)
    • do not take the Day and Night products at the same time; wait 4 hours after the last Day dose before starting Night product
    • adults and children 12 years and over: 2 tablets at bedtime and every 6 hours if needed, while symptoms persist, not more than 4 tablets in a 12 hour period
    • children under 12 years of age: ask a doctor
  • Other Information

    • store between 20° to 25°C (68° to 77°F)
    • protect from excessive moisture
    • this product meets the requirements of USP Dissolution Test 2
  • Inactive Ingredients

    carnauba wax, FD&C red No. 40 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

  • Questions or comments?

    Call 1-800-317-2165 (MoN-Fri 9AM-5PM EST)

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    DUAL FORMULA PACK

    Coricidin ®

    HBP

    Decongestant-free COLD RELIEF for people

    with HIGH BLOOD PRESSURE

    DAY

    MULTI-SYMPTOM COLD

    Guaifenesin - Expectorant

    Dextromethorphan HBr - Cough Suppressant

    Day Relieves:

    • Chest Congestion
    • Cough

    16 DAY SOFTGELS

    NIGHT

    Chlorpheniramine Maleate - Antihistamine,

    Dextromethorphan HBr - Cough Suppressant,

    Acetaminophen - Pain Reliever/Fever Reducer

    See New Warnings Information

    Night Relieves:

    • Runny Nose & Sneezing
    • Cough • Body Aches
    • Fever

    8 NIGHT TABLETS

    dn

  • INGREDIENTS AND APPEARANCE
    CORICIDIN HBP  DAY AND NIGHT
    dextromethorphan hydrobromide, guaifenesin, acetaminophen, chlorpheniramine maleate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-4765
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-4765-11 in 1 CARTON; Type 0: Not a Combination Product08/28/2009
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 12 BLISTER PACK 16 
    Part 22 BLISTER PACK 8 
    Part 1 of 2
    CORICIDIN HBP  DAY
    dextromethorphan hydrobromide and guaifenesin capsule, gelatin coated
    Product Information
    Item Code (Source)NDC:11523-4221
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code C;DAY
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-4221-12 in 1 CARTON
    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 finalpart34108/28/2009
    Part 2 of 2
    CORICIDIN HBP  NIGHT
    acetaminophen, chlorpheniramine maleate and dextromethorphan hydrobromide tablet
    Product Information
    Item Code (Source)NDC:11523-4111
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code C;NIGHT
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-4111-12 in 1 CARTON
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/28/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/28/2009
    Labeler - Bayer HealthCare LLC. (112117283)
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