LEADER CHEST CONGESTION RELIEF DM- dextromethorphan hydrobromide / guaifenesin tablet

Leader Chest Congestion Relief by

Drug Labeling and Warnings

Leader Chest Congestion Relief by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Reese Pharmaceutical Co, Pharbest. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient - (per tablet)

Dextromethorphan Hydrobromide   20mg

Guaifenesin  400mg

PURPOSE

Purpose

Cough Suppressant

Expectorant

Uses

■ Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold
■ Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
■ Helps make coughs more productive.

Warnings

Do not use  ■ if you are now taking a prescription monoamine oxidase (inhiMor~MAIO) (Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease)or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains an MAIO, ask your doctor or pharmacist before using this product.

ASK DOCTOR

Ask doctor before use if you have
■ persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysma
■ cough is accompanied by excessive phlegm (mucus)

STOP USE

Stop use and ask doctor if

■ symptoms are accompanied by fever, rash or persistent headache
■ cough persists for more than 1 week or tends to recur.
A persistent cough may be a sign of a serious condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In  case of overdose, get medical help or contact a Poison Center immediately.

DOSAGE & ADMINISTRATION

Directions
■ Adults and children 12 years of age and over:take 1 tablet every 4 hours as needed.
■ Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed.
■ Children under 6 years of age: consult a doctor.   
Do not exceed 6 doses in a 24 hour period or as directed by a doctor

Other Information

Store at 15°-30°C (59°-86°F)

INACTIVE INGREDIENT

Inactive Ingredients magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER CHEST CONGESTION RELIEF  DM
dextromethorphan hydrobromide / guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0056
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	400 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	17mm
Flavor		Imprint Code	PH073
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0056-1	1 in 1 CARTON	09/01/2020
1		60 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/01/2020

Labeler - Cardinal Health (063997360)

Registrant - Reese Pharmaceutical Co (004172052)

Establishment
Name	Address	ID/FEI	Business Operations
Pharbest		557054835	manufacture(70000-0056)