FDA.reportPublic FDA data

Coricidin HBP Maximum Strength Cold, Cough and Flu

Manufacturer
Bayer HealthCare LLC.
Effective date
2023-11-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:19:38

Label at a glance#

ProductCoricidin HBP Maximum Strength Cold, Cough and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 30 mL) Purposes
Acetaminophen 650 mgPain reliever/fever reducer
Dextromethorphan hydrobromide 20 mgCough suppressant
Guaifenesin 400 mgExpectorant

INDICATIONS & USAGE SECTION

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 SECTION

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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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 excessive phlegm (mucus)
• a sodium-restricted diet

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • fever gets worse or lasts more than 3 days
  • pain or cough gets worse or lasts more than 7 days
  • new symptoms occur
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions
• do not take more than recommended dose

• adults and children 12 years and over: take 30 mL in the dosing cup provided every 4 hours. Do not exceed 150 mL (5 doses) in 24 hours or as directed by a doctor.

• children under 12 years of age: do not use

OTHER SAFETY INFORMATION

Other information
• each 30 mL contains: sodium 38 mg
• store between 20º to 25ºC (68º to 77ºF)

INACTIVE INGREDIENT SECTION

Inactive ingredients anhydrous citric acid, FD&C blue #1, FD&C red # 40, flavor, glycerin, maltitol solution, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New!

Coricidin®

HBP COLD RELIEF FOR PEOPLE WITH

HIGH BLOOD PRESSURE†

MAXIMUM STRENGTH

COLD,

COUGH

& FLU

Relieves

Body Aches & Pains,

Headache, Fever,

Cough, Sore Throat,

Chest Congestion

SUGAR FREE

Alcohol Free

†Decongestant Free

Acetaminophen

Pain Reliever/ Fever Reducer

Dextromethorphan HBr-

Cough Suppressant

Guaifenesin-Expectorant

Cherry Flavor

12 FL OZ (355 mL)

Carton labelCarton label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-007611523-0076-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
MALTITOLD65DG142WKIACT
GLYCERINPDC6A3C0OXIACT
GUAIFENESIN495W7451VQACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1b2f01ab-a434-f7da-e063-6394a90aaf2ec4ba51b8-e86f-4227-e053-2995a90a853e2024-06-18WarningsExact identifier
spl set id: c4ba51b8-e86f-4227-e053-2995a90a853e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.