LEADER ADULT TUSSIN MUCUS AND CHEST CONGESTION 541- guaifenesin liquid

Leader Adult Tussin Mucus and Chest Congestion 541 by

Drug Labeling and Warnings

Leader Adult Tussin Mucus and Chest Congestion 541 by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH 110, LLC. DBA LEADER, Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

Guaifenesin, USP 200 mg 

PURPOSE

Expectorant

USE(S)

• helps loosen phlegm(mucus) and thin bronchial secretions to drain bronchial tubes

WARNINGS

.

ASK A DOCTOR BEFORE USE IF YOU HAVE

• cough that occurs with too much phlegm(mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

STOP USE AND ASK DOCTOR IF

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 

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 right away.

DIRECTIONS

shake well before using 

do not take more than 6 doses in any 24-hour period 

measure only with dosing cup provided

keep dosing cup with product 

ml=milliliter

this adult product is not intended for use in children under 12 years of age

• Age: Dose
• adults & children 12 years & over: 10 mL to 20 mL every 4 hours
• children under 12 years: ask a doctor

OTHER INFORMATION

• each 10 mL contains: sodium 12 mg 
• store at 20-25oC(68-77oF)
• protect from light

INACTIVE INGRADIENTS

caramel color, citric acid anhydrous, FD&C red# 40 dye, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, saccharine sodium, sodium benzoate.  

QUESTIONS OR COMMENTS?

(609) 860-2600

PRINCIPAL DISPLAY PANEL

LEADER TM

NDC70000-0696-1

Adult Tussin

Mucus + Chest Congestion

Guaifenesin, USP 200 mg per 10 mL

Expectorant

Cherry Flavor 

For Ages 12 and Over

Loosens and Relieves Mucus and 

Chest Congestion

100% Money Back Guarantee

4FL OZ(118 mL)

LEADER TM

NDC70000-0696-2

Adult Tussin

Mucus + Chest Congestion

Guaifenesin, USP 200 mg per 10 mL

Expectorant

Cherry Flavor 

For Ages 12 and Over

Loosens and Relieves Mucus and 

Chest Congestion

100% Money Back Guarantee

8FL OZ (237 mL)

INGREDIENTS AND APPEARANCE

LEADER ADULT TUSSIN MUCUS AND CHEST CONGESTION 541 
guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0696
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARAMEL (UNII: T9D99G2B1R)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0696-1	1 in 1 CARTON	09/20/2024
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 70000-0696-2	1 in 1 CARTON	09/20/2024
2		237 mL 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 Drug	M012	09/20/2024

Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	MANUFACTURE(70000-0696)