Label: CORICIDIN HBP MAXIMUM STRENGTH COLD AND FLU DAY AND NIGHT- acetaminophen, dextromethorphan hydrobromide, guaifenesin, doxylamine succinate kit

  • 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

    Coricidin HBP® Maximum Strength Cold & Flu Day Liquid Gels

  • Active ingredients

    Active ingredients (in each capsule) Purposes

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

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

  • Purpose

  • Uses

    Uses

    · temporarily relieves these symptoms due to a cold or flu:

    · minor aches and pains · headache

    · sore throat

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

    coughs 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 have ever had an allergic reaction to this product or any of its

    ingredients

    ● in children under 12 years of age

    Aska a doctor

    Ask a doctor before use if you have

    ● liver disease

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

    or emphysema

    ● cough that occurs with excess phelgm

    Ask a doctor or pharmacist

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

    Stop use

    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

    · do not take the Day and Night products at the same time; wait 4

    hours after taking the last Night dose before taking the Day product.

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

    every 4 hours. Do not exceed 6 capsules in 12 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 ingrediens

    Inactive ingredientsFD&C Yellow#6, gelatin, glycerin, iron oxide black, lecithin, medium-chain triglycerides, mica, 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)

  • Coricidin HBP Maximum Stregth Cold & Flu Night Liquid Gels

  • ACTIVE INGREDIENT

    Active ingredients (in each capsule)Purposes

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

    Dextromethorphan hydrobromide 10 mg……………Cough suppressant

    Doxylamine succinate 6.25 mg……………………………...Antihistamine

  • PURPOSE

  • USES

    • temporarily relieves these symptoms due to a cold or flu:
    • minor aches and pains · headache · cough
    • sore throat · runny nose · sneezing
    • temporarily reduces fever
  • Liver Warning

    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 to sedate children

    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 DOCTOR

  • ASK DOCTOR/PHARMACIST

    Ask a doctor before use if you have

    ● liver disease ● glaucoma

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

    or emphysema

    ● cough that occurs with excessive phlegm (mucus)

    ● a breathing problem such as emphysema or chronic bronchitis

    ● difficulty in urination due to enlargement of the prostate gland

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

  • WHEN USING

    When using this product
    ● may cause marked drowsiness
    ● avoid alcoholic beverages
    ● alcohol, sedatives, and tranquilizers may increase drowsiness
    ● be careful when driving a motor vehicle or operating machinery
    ● excitability may occur, especially in children

  • STOP USE

    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

  • PREGNANCY 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.

  • DOSAGE & ADMINISTRATION

    Directions

    · do not take more than the recommended dose

    · do not take the Day and Night products at the same time; wait 4

    hours after taking the last Day dose before taking the Night product.

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

    every 4 hours. Do not exceed 4 capsules in 12 hours or as

    directed by a doctor.

    · children under 12 years of age: do not use

  • OTHER SAFETY INFORMATION

    Other information

    · store at 15º-25ºC (59º-77ºF)

  • INACTIVE INGREDIENT

    Inactive ingredients D&C yellow No.10, FD&C blue No.1, gelatin, glycerin, lecithin, medium-chain triglycerides, silica, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, soybean oil, titanium dioxide

  • QUESTIONS

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

  • SPL UNCLASSIFIED SECTION

    Coricidin® HBP Maximum Strength Cold & Flu Liquid Gels

  • PRINCIPAL DISPLAY PANEL

    Coricidin Combo-22Coricidin® HBP

    COLD RELIEF FOR PEOPLE WITH HIGH BLOOD PRESSUREƗ

    MAXIMUM STRENGTH

    COLD & FLU DAY

    ACETAMINOPHEN - Pain Reliever/Fever Reducer

    GUAIFENESIN - Expectorant

    Relieves

    • Body Aches & Pains
    • Headache
    • Chest Congestion
    • Sore Throat
    • Fever

    Ɨ Decongestant Free

    16 LIQUID GELS

    (Liquid Filled Capsules)

    COLD & FLU NIGHT

    DOXYLAMINE SUCCINATE - Antihistamine

    ACETAMINOPHEN - Pain Reliever/Fever Reducer

    DEXTROMETHORPHAN HBr- Cough Suppressant

    RELIEVES

    • Body Aches & Pains
    • Headache
    • Runny Nose & Sneezing
    • Cough
    • Sore Throat
    • Fever

    Ɨ Decongestant Free

    8 LIQUID GELS

    (Liquid Filled Capsules)

  • INGREDIENTS AND APPEARANCE
    CORICIDIN HBP MAXIMUM STRENGTH COLD AND FLU DAY AND NIGHT 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, doxylamine succinate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0100
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-0100-11 in 1 BLISTER PACK; Type 0: Not a Combination Product07/01/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 14 BLISTER PACK
    Part 22 BLISTER PACK
    Part 1 of 2
    CORICIDIN HBP MAXIMUM STRENGTH COLD AND FLU DAY 
    acetaminophen, guaifenesin capsule, liquid filled
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SHELLAC (UNII: 46N107B71O)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN (UNII: 6O92ICV9RU)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POTASSIUM ALUMINUM DISILICATE (UNII: SRB14JRX6C)  
    POVIDONE (UNII: FZ989GH94E)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVAL (oblong) Size18mm
    FlavorImprint Code CHBPD
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12 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
    Part 2 of 2
    CORICIDIN HBP MAXIMUM STRENGTH COLD AND FLU NIGHT 
    acetaminophen, doxylamine succinate, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SHELLAC (UNII: 46N107B71O)  
    SORBITAN (UNII: 6O92ICV9RU)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITOL (UNII: 506T60A25R)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code CHBPN
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12 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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/01/2020
    Labeler - Bayer HealthCare LLC. (112117283)