Coricidin HBP Maximum Strength Cold and Flu Day and Night

Manufacturer
Bayer HealthCare LLC.
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:20:08

Label at a glance#

ProductCoricidin HBP Maximum Strength Cold and Flu Day and Night
Active ingredientACETAMINOPHEN, GUAIFENESIN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure23 sections

Indications and 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

Dosage and 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 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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Coricidin HBP® Maximum Strength Cold & Flu Day Liquid Gels

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each capsule) Purposes

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

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

Uses

INDICATIONS & USAGE SECTION

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 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.

Do not use

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

ingredients

● in children under 12 years of age

Aska a doctor

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 excess phelgm

Ask a doctor or pharmacist

OTC - ASK DOCTOR/PHARMACIST SECTION

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

Stop use

OTC - STOP USE 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.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children

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.

Directions

DOSAGE & ADMINISTRATION SECTION

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 SAFETY INFORMATION

Other information

· store at 15º-25ºC (59º-77ºF)

Inactive ingrediens

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

OTC - ACTIVE INGREDIENT SECTION

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

USES

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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 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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

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

OTC - STOP USE 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 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 SECTION

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

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Coricidin® HBP Maximum Strength Cold & Flu Liquid Gels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Coricidin Combo-22Coricidin 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)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2612689{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral Capsule) / 1 (acetaminophen 325 MG / guaifenesin 200 MG Oral Capsule) } PackGPCK5
26126891 daytime (acetaminophen 325 MG / guaiFENesin 200 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG Oral Capsule) PackPSN5
1426334acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG Oral CapsulePSN5
707195acetaminophen 325 MG / guaiFENesin 200 MG Oral CapsulePSN5
1426334acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral CapsuleSCD5
707195acetaminophen 325 MG / guaifenesin 200 MG Oral CapsuleSCD5
26126891 daytime (acetaminophen 325 MG / guaifenesin 200 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral Capsule) PackSY5
1426334APAP 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral CapsuleSY5
707195APAP 325 MG / Guaifenesin 200 MG Oral CapsuleSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0100-1Coricidin HBP Maximum Strength Cold and Flu Day and Night1 in 1 BLISTER PACKKIT15

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-010011523-0100-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

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
Coricidin HBP Maximum Strength Cold and Flu Day and NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATEBayer HealthCare LLC.e4f3f906-2252-21d1-e053-2a95a90a85df2025-12-04WarningsExact identifier
ndc (package): 11523-0100-1
ndc (product): 11523-0100
ndc11 (package): 11523010001
spl id: 4526d94e-3913-f1e0-e063-6294a90aefc0
spl set id: e4f3f906-2252-21d1-e053-2a95a90a85df

Reported adverse events (FAERS/openFDA)#

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