LEADER COUGH TABS- guaifenesin tablet

Leader Cough Tabs by

Drug Labeling and Warnings

Leader Cough Tabs by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Reese Pharmaceutical Co, Advance Pharmaceutical Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (per tablet)

Guaifenesin  200mg

Purpose

Expectorant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus 
• helps make coughs more productive

Warnings

Ask doctor before use if you have

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

Center immediately.

Directions

• Adults and children 12 years of age and over: take 1 to 2 tablets every 4 hours as needed
• Children 6 to 10 under 12 years of age: take 1/2 to 1 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 ingredients

FD C red No. 40 (Al-lake), magnesium stearate,  maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER COUGH TABS 
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-466
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	200 mg

Inactive Ingredients
Ingredient Name	Strength
MALTODEXTRIN (UNII: 7CVR7L4A2D)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POVIDONE (UNII: FZ989GH94E)
MAGNESIUM STEARATE (UNII: 70097M6I30)
FD&C RED NO. 40 (UNII: WZB9127XOA)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	red (rose)	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	151
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-466-72	1 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/01/2005

Labeler - Cardinal Health (097537435)

Registrant - Reese Pharmaceutical Co (004172052)

Establishment
Name	Address	ID/FEI	Business Operations
Reese Pharmaceutical Co		004172052	relabel(37205-466) , repack(37205-466)

Establishment
Name	Address	ID/FEI	Business Operations
Advance Pharmaceutical Inc		187824339	manufacture(37205-466)