Coricidin HBP Maximum Strength Cold and Flu Day and Night

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 21:19:33

Label at a glance#

ProductCoricidin HBP Maximum Strength Cold and Flu Day and Night
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, ACETAMINOPHEN, DOXYLAMINE SUCCINATE
Label structure18 sections

Indications and 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 rid the bronchial passageways of bothersome mucus and make cough 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

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each capsule) Purposes

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

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

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

Uses

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 rid

the bronchial passageways of bothersome mucus and make

cough 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 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

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,

or emphysema

● cough with excessive phlegm (mucus)

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 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?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Coricidin® HBP Maximum Strength Cold & Flu Night Liquid Gels

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

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

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

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 to sedate children

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 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

OTC - ASK DOCTOR 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 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

● taking the blood thinning drug warfarin

● taking sedatives or tranquilizers

When using this product

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

Stop use and ask a doctor if

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 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 information

OTHER SAFETY INFORMATION

Other information

· store at 15º-25ºC (59º-77ºF)

Questions or Comments

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 PRESSUREƗ

MAXIMUM STRENGTH

COLD & FLU DAY

GUAIFENESIN - Expectorant

DEXTROMETHORPHAN HBr - Cough Supressant

ACETAMINOPHEN - Pain Reliever/Fever Reducer

Relieves

  • Body Aches & Pains
  • Headache
  • Chest Congestant
  • Cough
  • Sore Throat
  • Fever

Ɨ Decongestant Free

16 LIQUID GELS

(Liquid Filled Capsules)

COLD & FLU NIGHT

DOXYLAMINE SUCCINATE - Antihistamine

DEXTROMETHORPHAN HBr - Cough Suppresant

ACETAMINOPHEN - Pain Reliever/Fever Reducer

RELIEVES

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

Ɨ Decongestant Free

8 LIQUID GELS

(Liquid Filled Capsules)

Carton 24 countCarton 24 count

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-002611523-0026-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 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
1b2ef587-da7c-b9c2-e063-6394a90a2185a4722601-10c3-21a7-e053-2995a90a161a2024-06-18WarningsExact identifier
spl set id: a4722601-10c3-21a7-e053-2995a90a161a

Reported adverse events (FAERS/openFDA)#

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