CORICIDIN HBP COUGH AND COLD- chlorpheniramine maleate, dextromethorphan hydrochloride tablet

Coricidin HBP Cough and Cold by

Drug Labeling and Warnings

Coricidin HBP Cough and Cold by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each tablet) Purpose

Chlorpheniramine maleate 4 mg………………………….....................Antihistamine

Dextromethorphan hydrobromide 30 mg……………………… .Cough suppressant

PURPOSE

INDICATIONS & USAGE

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

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.
• if you have ever had an allergic reaction to this product or any of its ingredients
• in children under 12 years of age

Do not use to sedate children.

Ask a doctor before use if you have

• trouble urinating due to an enlarged prostate gland
• cough that occurs with excessive phlegm (mucus)
• a breathing problem such as emphysema or chronic bronchitis
• persistent or chronic cough such as occurs with smoking, asthma, 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
• avoid alcoholic beverages
• alcohol, sedatives and tranquilizers may increase drowsiness
• use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if cough persists for more than 7 days, 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. Abuse of this product can lead to serious injury.

DOSAGE & ADMINISTRATION

Directions

• do not exceed recommended dose
• adults and children 12 years and over: take 1 tablet every 6 hours, not more

than 4 tablets in 24 hours

• children under 12 years of age: do not use

OTHER SAFETY INFORMATION

Other information

• store between 20º to 25ºC (68º to 77ºF)
• see end flap for expiration date and lot number

INACTIVE INGREDIENT

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

Questions or comments? 1-800-317-2165 (Mon-Fri 9AM - 5PM EST)

HOW SUPPLIED

Product: 50090-5534

NDC: 50090-5534-0 8 TABLET in a BLISTER PACK / 2 in a CARTON

CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDE

INGREDIENTS AND APPEARANCE

CORICIDIN HBP COUGH AND COLD 
chlorpheniramine maleate, dextromethorphan hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50090-5534(NDC:11523-0008)
Route of Administration	ORAL

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

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50090-5534-0	2 in 1 CARTON	05/04/2021
1		8 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	10/23/2020

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-5534)