Label: CORICIDIN HBP MAXIMUM STRENGTH COLD, COUGH AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 30, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Active ingredients (in each capsule) Purposes

    Acetaminophen 325 mg…………….………..Pain reliever/fever reducer

    Dextromethorphan hydrobromide 10 mg…………..Cough suppressant

    Guaifenesin 200 mg…………………………………………...Expectorant

  • Purpose

  • Uses

    Uses

    · temporarily relieves these symptoms due to a cold or flu: · minor aches and pains · headache · cough · sore throat

    · helps loosen phlegm ( mucus) and thin bronchial secretions to make cough more productive

    · temporarily reduces fever

  • 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.

    Do not use

    Do not use

    ● with any other drug containing acetaminophen (prescription or

    nonprescription). 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

    an MAOI, ask a doctor or pharmacist before taking this product.

    ● if you have ever had an allergic reaction to this product or any of its

    ingredients

    ● in children under 12 years of age

    Ask a doctor before use if you have

    Ask a doctor before use if you have

    ● liver disease

    ● persistent or chronic cough such as occurs with smoking, asthma,

    or emphysema

    ● cough is accompanied by excessive phlegm (mucus)

    Ask a doctor or pharmacist

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    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 rash or headache that lasts.

    These could be signs of a serious condition.

    If pregnant or breast-feeding

    If pregnant or breast-feeding, ask a health professional before 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    Directions

    · do not take more than the recommended dose

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

    every 4 hours. Do not exceed 10 capsules in 24 hours or as

    directed by a doctor.

    · children under 12 years of age: do not use

  • Other information

    Other information

    ● store at 15º-25ºC (59º-77ºF)

  • Inactive ingredients

    Inactive ingredients FD&C red No.40, gelatin, glycerin, iron oxide black, lecithin, medium-chain triglycerides, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

  • Questions or comments

    Questions or comments?1-800-317-2165 (Mon-Fri 9AM -5PM EST)

  • Package label - 24 count carton

    Coricidin®

    HBP

    COLD RELIEF FOR PEOPLE WITH

    HIGH BLOOD PRESSURE Ɨ

    MAXIMUM STRENGTH

    COLD,

    COUGH

    & FLU

    Relieves

    • Body aches & Pains
    • Headache
    • Fever
    • Cough
    • Sore Throat
    • Chest Congestion

    ƗDecongestant Free

    24 LIQUID GELS

    (Liquid-Filled Capsules)

    Carton 24 count

  • INGREDIENTS AND APPEARANCE
    CORICIDIN HBP MAXIMUM STRENGTH COLD, COUGH AND FLU 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0006
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    SORBITAN (UNII: 6O92ICV9RU)  
    POVIDONE (UNII: FZ989GH94E)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN (UNII: 2G86QN327L)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POTASSIUM ALUMINUM DISILICATE (UNII: SRB14JRX6C)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code CHBPD
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-0006-12 in 1 CARTON07/01/2020
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/01/2020
    Labeler - Bayer HealthCare LLC. (112117283)