Cough and Cold

Medically reviewed by Drugs.com. Last updated on Jul 22, 2020.

Dosage form: tablet, coated
Ingredients: CHLORPHENIRAMINE MALEATE 4mg, DEXTROMETHORPHAN HYDROBROMIDE 30mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-6634

Major 44-689

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 (1-800-222-1222) 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
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?

(800) 616-2471

Principal Display Panel

Major®

NDC 0904-6634-44

Compare to the active ingredients in Coricidin® HBP Cough & Cold*

Cough &
Cold Relief for people with High Blood Pressure
Chlorpheniramine maleate - Antihistamine
Dextromethorphan HBr - Cough Suppressant

Decongestant Free

Relieves
• Cough • Runny Nose • Sneezing

16 TABLETS

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

*This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Coricidin® HBP COUGH & COLD.

50844 ORG111668921

Distributed by MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA
Re-order No. 700844

Major 44-689

COUGH AND COLD
chlorpheniramine maleate, dextromethorphan hbr tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-6634
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE)	CHLORPHENIRAMINE MALEATE	4 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM
D&C RED NO. 27 ALUMINUM LAKE
FD&C YELLOW NO. 6
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
STEARIC ACID
TALC
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED

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

Packaging
#	Item Code	Package Description
1	NDC:0904-6634-44	2 BLISTER PACK in 1 CARTON
1		8 TABLET, COATED in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/31/2017