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Flu HBP by Walgreen Company

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg, DEXTROMETHORPHAN HYDROBROMIDE 15mg, CHLORPHENIRAMINE MALEATE 2mg
Labeler: Walgreen Company
NDC Code: 0363-0461

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Walgreens 44-461

Active ingredients (in each tablet)

Acetaminophen 500 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 15 mg 

Purpose

Pain reliever/fever reducer
Antihistamine
Cough suppressant 

Uses
  • temporarily relieves:
    • minor aches and pains
    • sneezing
    • runny nose
    • cough
    • headache
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur in you take:

  • more than 4,000 mg 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: 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.

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

Ask a doctor before use if you have
  • difficulty in urination due to enlargement of the prostate gland
  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • glaucoma
  • 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
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product
  • avoid alcoholic beverages
  • may cause marked drowsiness
  • 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
  • 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,

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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
  • do not take more than directed
  • adults and children 12 years and over: 2 tablets every 6 hours while symptoms persist. Do not take more than 6 tablets in 24 hours.
  • children under 12 years: ask a doctor

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

Inactive ingredients

corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

Well at
Walgreens

WALGREENS PHARMACIST RECOMMENDEDǂ

NDC 0363-0461-09

MAXIMUM
STRENGTH

FLU HBP
Acetaminophen /

Pain Reliever / Fever Reducer
Chlorpheniramine Maleate / Antihistamine
Dextromethorphan HBr /
Cough Suppressant

• Relieves body aches, headaches, runny nose,
   fever, cough & sneezing

• Maximum strength flu relief for people
   with high blood pressure

20
TABLETS

Actual Size

Compare to Coricidin® HBP
Maximum Strength Flu
active ingredientsǂǂ

DECONGESTANT FREE

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
Walgreens
100% SATISFACTION GUARANTEED
walgreens.com    ©2016 Walgreen Co.

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

ǂ Walgreens Pharmacist Survey Study, November 2014.

ǂǂ This product is not manufactured or distributed by Bayer Healthcare LLC, owner of the registered trademark Coricidin® HBP Maximum Strength Flu.

50844    REV1016C46109

Walgreens 44-461

FLU HBP 
acetaminophen, dextromethorphan hbr, chlorpheniramine maleate tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0461
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
SILICON DIOXIDE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
STARCH, CORN 
CROSPOVIDONE 
D&C YELLOW NO. 10 
FD&C RED NO. 40 
Product Characteristics
ColorREDScoreno score
ShapeOVALSize18mm
FlavorImprint Code44;461
Contains    
Packaging
#Item CodePackage Description
1NDC:0363-0461-092 BLISTER PACK in 1 CARTON
110 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/01/2005
Labeler - Walgreen Company (008965063)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(0363-0461)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(0363-0461)

Revised: 01/2017
 
Walgreen Company

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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