FLU HBP- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr tablet, film coated
CVS Pharmacy

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.

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CVS 44-461-Delisted

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 if 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 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

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

♥︎CVS
Health™

Compare to the active ingredients in Coricidin® HBP Maximum Strength Flu*

Decongestant Free NDC 59779-461-09

MAXIMUM STRENGTH

Flu HBP

ACETAMINOPHEN - Pain reliever / Fever reducer

CHLORPHENIRAMINE MALEATE - Antihistamine

DEXTROMETHORPHAN HBr - Cough suppressant

For people with high blood pressure

Relieves:

●Body aches, pains
& headache
●Fever
●Cough
●Runny nose

20 TABLETS

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 REV1016A46109

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com® 1-800-SHOP CVS

V-19849
CVS 44-461

CVS 44-461

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-461
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (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)
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 2S7830E561)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
FD&C RED NO. 40 (UNII: WZB9127XOA)
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59779-461-09	2 in 1 CARTON	06/01/2005	02/11/2022
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	06/01/2005	02/11/2022

Labeler - CVS Pharmacy (062312574)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(59779-461)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	PACK(59779-461)

Revised: 10/2020

Document Id: 64be3641-070a-4b74-9647-1393d5a710d9

Set id: 3fcb4b21-ec8a-205f-980e-d5fdabb43acd

Version: 10

Effective Time: 20201028

CVS Pharmacy