LEADER CHEST CONGESTION RELIEF PE- guaifenesin/phenylephrine 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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Guaifenesin                             400 mg

Phenylephrine HCl                   10 mg

PURPOSE

Guaifenesin                               Expectorant

Phenylephrine HCl                   Nasal decongestant

INDICATIONS & USAGE

temporarily relieves symptoms associated with a cough ,the common cold,hay fever or other upper respiratory allergies.

helps loosen phlegm;mucus

clear nasal passageways

loosens nasal congestion

drain bronchial tubes

shrinks swollen membranes

clears stuffy nose

makes coughs more productive

WARNINGS

do not exceed recommended dosage

DO NOT USE

Do not use this product if you are now taking a prescription Monoamine Oxidase inhibitor ; MAIO,

certain drugs for depression,psychiatric or emotional conditions, or Parkinsons Disease or for 2 weeks

after stopping the MAIO drug,if you are uncertain whether your prescription contains an MAIO ,

ask a health professional.

ASK DOCTOR

ask a doctor before use if you have

heart disease

high blood pressure

thyroid disease

diabetes

excessive phlegm;mucus

difficulty in urination due to an enlarged prostate gland

persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis or emphysema

STOP USE

stop use and ask a doctor if

nervousness,dizziness or sleeplessness occurs

symptoms are accompanied by fever,rash,persistent headache or excessive phlegm;mucus.

cough and congestion do not approve within 7 days or tend to recur

these could be signs of a serious condition

PREGNANCY 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 immediately.

DOSAGE & ADMINISTRATION

directions

Adults and Children 12 years of age and over take 1 caplet every 4 hours as needed

children 6 to under 12 years of age consult a doctor

do not exceed 6 doses in a 24 hour period or as directed by a doctor.

INACTIVE INGREDIENT

croscarmellose sodium,hypromellose,lactose,magnesium silicate,

magnesium stearate,maltodextrin,mycocrystalline cellulose,mineral oil,povidone,

silica,sodium lauryl sulfate,stearic acid,titanium oxide and triacetin.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER CHEST CONGESTION RELIEF  PE
guaifenesin/phenylephrine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-874
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	400 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE (UNII: J2B2A4N98G)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
POVIDONE (UNII: FZ989GH94E)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	17mm
Flavor		Imprint Code	RCCGPE;C27
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-874-01	1 in 1 CARTON
1	NDC: 37205-874-71	50 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/05/2006

Labeler - Cardinal Health (097537435)

Registrant - Reese Pharmaceutical Co (004172052)

Establishment
Name	Address	ID/FEI	Business Operations
Reese Pharmaceutical Co		004172052	relabel, repack