FDA.reportPublic FDA data

Walgreens 44-738

Manufacturer
Walgreen Company | LNK International, Inc.
Effective date
2026-05-08
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:56:36

Label at a glance#

ProductFlu HBP Maximum Strength
Active ingredientACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure9 sections

Indications and uses

temporarily relieves these common cold and flu symptoms: minor aches and pains sore throat sneezing headache runny nose cough temporarily reduces fever

Dosage and administration

do not take more than directed adults and children 12 years and over: take 2 caplets every 4 hours while symptoms persist. Do not take more than 10 caplets in 24 hours. children under 12 years: ask a doctor

Storage and handling

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number protect from excessive moisture

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 10 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Antihistamine
Cough suppressant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these common cold and flu symptoms:
    • minor aches and pains
    • sore throat
    • sneezing
    • headache
    • runny nose
    • cough
  • 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 reactions. Symptoms may include:

  • blisters
  • rash
  • skin reddening

If a skin 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 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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • difficulty in urination due to enlargement of the prostate gland
  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain or cough gets worse or lasts more than 7 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • 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

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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 2 caplets every 4 hours while symptoms persist. Do not take more than 10 caplets in 24 hours.
  • children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
  • protect from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, crospovidone, FD&C red #40 aluminum lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0363-7380-08

Walgreens

WALGREENS PHARMACIST RECOMMENDED†

Compare to the active ingredients
in Coricidin® HBP Maximum
Strength Multi-Symptom Flu††

Flu HBP
ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER
CHLORPHENIRAMINE MALEATE / ANTIHISTAMINE
DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

Maximum Strength    Decongestant Free

• Relieves body aches, pains, headache,
runny nose, fever, cough, sore throat & sneezing
• For people with high blood pressure

24
CAPLETS

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

†Our pharmacists recommend the Walgreens brand.
We invite you to compare to national brands.

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2022 Walgreen Co.

PARENTS:
Learn about teen medicine abuse
www.stopmedicineabuse.org

††This product is not manufactured or
distributed by Bayer HealthCare LLC, owner
of the registered trademark Coricidin® HBP
Maximum Strength Multi-Symptom Flu.

50844  ORG101973808

Walgreens 44-738
Walgreens 44-738

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2049841acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG Oral TabletPSN10
2049841acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG Oral TabletSCD10
2049841acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG Oral TabletSY10
2049841APAP 325 MG / Chlorpheniramine Maleate 2 MG / Dextromethorphan Hydrobromide 10 MG Oral TabletSY10

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130311917009483GTIN-13: 0311917009483
EAN-13: 0311917009483
GTIN-12: 311917009483
UPC-A: 311917009483
GTIN storage (14 digits): 00311917009483		walgreens-44-738-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-7380-08Flu HBPMaximum Strength12 in 1 BLISTER PACKTABLET, FILM COATED1210
0363-7380-08Flu HBPMaximum Strength2 in 1 CARTONTABLET, FILM COATED210
0363-7380-09Flu HBPMaximum Strength2 in 1 CARTONTABLET, FILM COATED210
0363-7380-09Flu HBPMaximum Strength10 in 1 BLISTER PACKTABLET, FILM COATED1010

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
0363-73800363-7380-08, 0363-7380-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
STARCH, CORNO8232NY3SJIACT
CROSPOVIDONE, UNSPECIFIED2S7830E561IACT
FD&C RED NO. 40 ALUMINUM LAKE6T47AS764TIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML · Source PDF

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
Flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRWalgreen Companyfac55d76-457f-4258-9cc8-6edae539cada2026-05-08WarningsExact identifier
ndc (package): 0363-7380-09
ndc (package): 0363-7380-08
ndc (product): 0363-7380
ndc11 (package): 00363738008
ndc11 (package): 00363738009
spl id: 12e377ac-d11a-4d0d-afc9-4736679ed997
spl set id: fac55d76-457f-4258-9cc8-6edae539cada

Reported adverse events (FAERS/openFDA)#

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