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NDC 00363-6890-21 Cough and Cold HBP 4; 30 mg/1; mg/1 Details

Cough and Cold HBP 4; 30 mg/1; mg/1

Cough and Cold HBP is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. The primary component is CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE.

MedlinePlus Drug Summary

Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine helps control the symptoms of cold or allergies but will not treat the cause of the symptoms or speed recovery. Chlorpheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 00363-6890-21
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Chlorpheniramine

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Related Packages: 00363-6890-21
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

Product Information

NDC	00363-6890
Product ID	0363-6890_17dba440-3130-4bac-888c-e79778f16a23
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Cough and Cold HBP
Proprietary Name Suffix	Maximum Strength
Non-Proprietary Name	Chlorpheniramine Maleate, Dextromethorphan Hbr
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, COATED
Route	ORAL
Active Ingredient Strength	4; 30
Active Ingredient Units	mg/1; mg/1
Substance Name	CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Labeler Name	Walgreen Company
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	n/a

Package

Package Images

NDC 00363-6890-21 (00363689021)

Pricing Information	N/A
NDC Package Code	0363-6890-21
Billing NDC	00363689021
Package	2 BLISTER PACK in 1 CARTON (0363-6890-21) / 8 TABLET, COATED in 1 BLISTER PACK
Marketing Start Date	2017-05-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a8306fc3-6d78-46ba-95d7-5fa55b2b2c29 Details

Active ingredients (in each tablet)

Chlorpheniramine maleate 4 mg

Dextromethorphan HBr 30 mg

Purpose

Antihistamine

Cough suppressant

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
temporarily relieves runny nose and sneezing due to the common cold

Warnings

Do not use

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.

Ask a doctor before use if you have

difficulty in urination due to enlargement of the prostate gland
cough that occurs with excessive 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 sedatives or tranquilizers.

When using this product

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

Stop use and ask a doctor if

persistent cough lasts for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache. 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 overdose, get medical help or contact a Poison Control Center right away.

Directions

do not exceed recommended dose
adults and children 12 years and over: 1 tablet every 6 hours, not more than 4 tablets in 24 hours
children under 12 years: do not use

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

Inactive ingredients

croscarmellose sodium, D&C red #27 aluminum lake, FD&C yellow #6 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

Walgreens

Compare to Coricidin®

HBP Cough & Cold

active ingredients††

NDC 0363-6890-21

MAXIMUM STRENGTH

Cough &

Cold HBP

CHLORPHENIRAMINE MALEATE / ANTIHISTAMINE

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

DECONGESTANT FREE

• Relieves cough, runny nose & sneezing

• Cough & cold relief for people with

high blood pressure

16

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

†Walgreens Pharmacist Survey

†† This product is not manufactured or distributed by Bayer

HealthCare LLC, owner of the registered trademark Coricidin®

HBP Cough & Cold.

50844 REV0121C68921

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

Walgreens

100% SATISFACTION GUARANTEED

walgreens.com ©2018 Walgreen Co.

Walgreens 44-689

INGREDIENTS AND APPEARANCE

COUGH AND COLD HBP MAXIMUM STRENGTH

chlorpheniramine maleate, dextromethorphan hbr tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-6890
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	44;689
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-6890-21	2 in 1 CARTON	05/15/2017	06/09/2024
1		8 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	05/15/2017	06/09/2024

Labeler - Walgreen Company (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(0363-6890)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(0363-6890)

Revised: 7/2022

Document Id: 17dba440-3130-4bac-888c-e79778f16a23

Set id: a8306fc3-6d78-46ba-95d7-5fa55b2b2c29

Version: 7

Effective Time: 20220706