LEADER INTENSE COUGH RELIEVER- dextromethorphan hydrobromide / guaifenesin liquid

LEADER iNTENSE COUGH RELIEVER by

Drug Labeling and Warnings

LEADER iNTENSE COUGH RELIEVER 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

Active ingredient per 5ml teaspoon

Dextromethorphan Hydrobromide   20mg   Cough Suppressant
Guaifenesin  300mg  Expectorant

INDICATIONS & USAGE

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 (mucous)

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 breastfeeding, 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) 

PURPOSE

Purpose


Dextromethorphan Hydrobromide      Cough Suppressant

Guaifenesin                                     Expectorant

INACTIVE INGREDIENT

Cherry Flavor,Citric Acid,Menthol,Polyethylene Glycol,Propylene Glycol,Purified Water,

Sodium Benzoate,Sodium Saccharin,Sorbitol.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER INTENSE COUGH RELIEVER 
dextromethorphan hydrobromide / guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-610
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  in 5 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	300 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
MENTHOL (UNII: L7T10EIP3A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-610-01	1 in 1 CARTON
1	NDC: 37205-610-26	120 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/02/2011

Labeler - Cardinal Health (097537435)

Registrant - Reese Pharmaceutical Co (004172052)

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