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 110, LLC. DBA Leader, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each caplet)

Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 10 mg

Purpose

Pain reliever/fever reducer
Antihistamine
Cough suppressant

Uses

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

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

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 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: 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

• 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)
• protect from excessive moisture
• see end flap for expiration date and lot number

Inactive ingredients

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?

1-800-200-6313

Principal Display Panel

LEADER™

NDC: 70000-0050-1

Maximum Strength
Multi-Symptom
Flu HBP

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

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

For People with
High Blood Pressure

Decongestant-Free

COMPARE TO
CORICIDIN® HBP
MULTI-SYMPTOM FLU
MAXIMUM STRENGTH
active ingredients*

100% Money Back Guarantee

20 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

50844
REV1019A73809

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

©2022 Cardinal Health. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks
or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

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

100%
Money Back
Guarantee
Return to place of purchase.

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

Leader 44-738

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: 70000-0050
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 2S7830E561)
FD&C RED NO. 40 (UNII: WZB9127XOA)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	44;738
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0050-1	2 in 1 CARTON	06/17/2020
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 Drug	M012	06/17/2020

Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	manufacture(70000-0050) , pack(70000-0050)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	manufacture(70000-0050)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		117025878	manufacture(70000-0050)