Coricidin HBP Maximum Strength Cold Flu And Chest Congestion

Manufacturer
Bayer HealthCare LLC.
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:20:07

Label at a glance#

ProductCoricidin HBP Maximum Strength Cold Flu And Chest Congestion
Active ingredientACETAMINOPHEN, GUAIFENESIN
Label structure13 sections

Indications and 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

• do not take more than the recommended dose • adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor. • children under 12 years of age: do not use

Storage and handling

● store at 15º-25ºC (59º-77ºF)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients

(in each tablet)
Purpose
Acetaminophen 325 mgPain reliever/ fever reducer
Guaifenesin 200 mgExpectorant

Uses

INDICATIONS & USAGE SECTION

  • 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

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

● 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

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 is accompanied by excessive phlegm (mucus)

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 • 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.

Directions

DOSAGE & ADMINISTRATION SECTION

• do not take more than the recommended dose
• adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not
exceed 10 capsules in 24 hours or as directed by a doctor.
• children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

● store at 15º-25ºC (59º-77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&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

?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL - 24 Liquid Gels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Coricidin ®


HIGH BLOOD PRESSURE



Acetaminophen - Pain Reliever/Fever Reducer

Guaifenesin - Expectorant

24 Liquid Gels

Coricidin Daytime Liquid GelsCoricidin Daytime Liquid Gels

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
707195acetaminophen 325 MG / guaiFENesin 200 MG Oral CapsulePSN8
707195acetaminophen 325 MG / guaifenesin 200 MG Oral CapsuleSCD8
707195APAP 325 MG / Guaifenesin 200 MG Oral CapsuleSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0094-1Coricidin HBP Maximum Strength Cold Flu And Chest Congestion12 in 1 BLISTER PACKCAPSULE, GELATIN COATED128
11523-0094-1Coricidin HBP Maximum Strength Cold Flu And Chest Congestion2 in 1 CARTONCAPSULE, GELATIN COATED28

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-009411523-0094-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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 Flu And Chest CongestionACETAMINOPHEN, GUAIFENESINBayer HealthCare LLC.de95d2dd-e766-f7ec-e053-2995a90afc5f2025-12-04WarningsExact identifier
ndc (package): 11523-0094-1
ndc (product): 11523-0094
ndc11 (package): 11523009401
spl id: 4526d3e1-16f9-f68e-e063-6294a90a029b
spl set id: de95d2dd-e766-f7ec-e053-2995a90afc5f

Reported adverse events (FAERS/openFDA)#

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