FDA.reportPublic FDA data

Coricidin HBP Nighttime Multi-Symptom Cold

Manufacturer
Bayer HealthCare LLC.
Effective date
2025-12-05
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:20:18

Label at a glance#

ProductCoricidin HBP Nighttime Multi-Symptom Cold
Active ingredientDOXYLAMINE SUCCINATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure16 sections

Indications and uses

temporarily relieves common cold/flu symptoms: headache sore throat runny nose minor aches and pains cough due to minor throat and bronchial irritation sneezing fever

Dosage and administration

do not take more than directed adults and children 12 years and over: take 30 mL in the dosing cup provided every 6 hours while symptoms last do not exceed 120 mL (4 doses) in 24 hours, unless directed by a doctor children under 12 years: ask a doctor

Label contents#

Full prescribing information#

Active ingredients (in each 15 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan hydrobromide 15 mgCough suppresant
Doxylamine succinate 6.25 mgAntihistamine

Purpose

OTC - PURPOSE SECTION

Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan hydrobromide 15 mgCough suppresant
Doxylamine succinate 6.25 mgAntihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • headache
  • sore throat
  • runny nose
  • minor aches and pains
  • cough due to minor throat and bronchial irritation
  • sneezing
  • fever

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 120 mL (4 doses) in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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 note use

OTC - DO NOT USE SECTION

  • with any other products containing acetaminophen (prescription or nonprescription). If you are no 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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • cough that occurs with too much phlegm (mucus)
  • glaucoma
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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. (1-800-222-1222) 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

  • do not take more than directed
  • adults and children 12 years and over: take 30 mL in the dosing cup provided every 6 hours while symptoms last
  • do not exceed 120 mL (4 doses) in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor

Other information

OTHER SAFETY INFORMATION

  • each 15 mL contains: sodium 18 mg
  • store at 20º-25ºC (68º-77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol 10%, anhydrous citric acid, FD&C blue no.1, FD&C red no.40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

nighttimeliqnighttimeliq

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSN7
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD7
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY7
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSY7
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSY7

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-4358-1Coricidin HBP Nighttime Multi-Symptom Cold355 mL in 1 BOTTLE, PLASTICLIQUID3557

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-4358-1ML - Milliliter11523-4358f39ec3fe-0711-424e-adea-d9e84229090512022-06-06

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-435811523-4358-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT

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 Nighttime Multi-Symptom ColdACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.513ca24f-1262-4a2d-e054-00144ff8d46c2025-12-05WarningsExact identifier
ndc (package): 11523-4358-1
ndc (product): 11523-4358
ndc11 (package): 11523435801
spl id: 45370f14-3c3a-b211-e063-6294a90ad8dc
spl set id: 513ca24f-1262-4a2d-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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