Coricidin HBP Maximum Strength Cold, Cough and Flu
- Manufacturer
- Bayer HealthCare LLC.
- Effective date
- 2024-12-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-06-01 00:41:10
Label at a glance#
ProductCoricidin HBP Maximum Strength Cold, Cough and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure9 sections
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
| Active ingredients (in each 30 mL) | Purposes |
| Acetaminophen 650 mg | Pain reliever/fever reducer |
| Dextromethorphan hydrobromide 20 mg | Cough suppressant |
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves these symptoms due to a cold or flu:
- minor aches and pains
- headache
- cough
- sore throat
- 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 or emphysema
- cough that is accompanied with excessive phlegm (mucus)
- a sodium-restricted diet
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
OTC - WHEN USING SECTION
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.
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 symptoms.
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 – 5PM EST)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Coricidin®
HBP
COLD RELIEF FOR PEOPLE WITH
HIGH BLOOD PRESSURE†
MAXIMUM STRENGTH
NIGHTTIME
COLD
& FLU
Relieves
Body Aches & Pains
Headache, Fever,
Cough, Sore Throat,
SUGAR FREE
Alcohol Free
Cherry
†Decongestant Free
Acetaminophen -
Pain Reliever/Fever Reducer
Dextromethorphan HBr-
Cough Suppressant
12 FL OZ (355 mL)
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2604561 | acetaminophen 650 MG / dextromethorphan HBr 20 MG in 30 mL Oral Solution | PSN | 6 |
| 2604561 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral Solution | SCD | 6 |
| 2604561 | acetaminophen 325 MG / dextromethorphan HBr 10 MG per 15 ML Oral Solution | SY | 6 |
| 2604561 | acetaminophen 650 MG / dextromethorphan HBr 20 MG per 30 ML Oral Solution | SY | 6 |
| 2604561 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral Solution | SY | 6 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11523-0093-1 | Coricidin HBP Maximum Strength Cold, Cough and Flu | 355 mL in 1 BOTTLE | LIQUID | 355 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11523-0093 | CORICIDIN HBP MAXIMUM STRENGTH COLD, COUGH AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BAYER HEALTHCARE LLC.] | 6 | Legacy NDC, 1 package rows | 20241208_dda48038-afe0-42fd-e053-2a95a90a836e.zip |
Products#
Every source-derived product name is available through these pages.
- Coricidin HBP Maximum Strength Cold, Cough and Flu
- acetaminophen, dextromethorphan hydrobromide
- PROPYLENE GLYCOL
- FD&C RED NO. 40
- WATER
- SACCHARIN SODIUM
- SODIUM CITRATE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- ANHYDROUS CITRIC ACID
- FD&C BLUE NO. 1
- GLYCERIN
- MALTITOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 11523-0093 | 11523-0093-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MALTITOL | D65DG142WK | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Coricidin HBP Maximum Strength Cold, Cough and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 351d3c5c-05c8-921a-e063-6394a90abef9 | 2025-12-04 | Warnings | 11523-0093-1 11523009301 |
| 289ddd77-a21e-307b-e063-6394a90ad6a7 | dda48038-afe0-42fd-e053-2a95a90a836e | 2024-12-06 | Warnings | 289ddd77-a21e-307b-e063-6394a90ad6a7 dda48038-afe0-42fd-e053-2a95a90a836e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.