FLU HBP MAXIMUM STRENGTH- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr tablet, film coated

Flu HBP by

Drug Labeling and Warnings

Flu HBP by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 these common cold and flu symptoms:

• minor aches and pains
• sour throat
• sneezing
• runny nose
• cough
• headache

• temporarily reduces fever

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 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

• 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 
• 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

• 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 15º-30ºC (59º-86ºF)
• 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

LEADER™

NDC: 70000-0138-1

Maximum Strength 

Flu HBP

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

Relieves:
Body Aches, Pains and Headache,
Fever, Cough, Runny Nose

For People with
High Blood Pressure

Decongestant-Free

20 TABLETS

100% Money Back Guarantee 

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

CIN 5285846     REV. 8/19

50844    REV0219A46109

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313

© 2019 Cardinal Health, All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO
LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health.

100% Money Back Guarantee
Return to place of purchase.

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

Leader 44-461

INGREDIENTS AND APPEARANCE

FLU HBP  MAXIMUM STRENGTH
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0138
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 2S7830E561)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	44;461
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0138-1	2 in 1 CARTON	06/01/2005
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/01/2005

Labeler - Cardinal Health (097537435)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(70000-0138)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(70000-0138)