LEADER MUCUS RELIEF- guaifenesin tablet, multilayer, extended release

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredient (in each extended-release tablet)

Guaifenesin 600 mg

Purpose

Expectorant

Uses

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

Warnings

Do not use

• for children under 12 years of age

Ask a doctor before use if you have

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough accompanied by too much phlegm (mucus)

Stop use and ask a doctor if

• cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

  These could be signs of a serious illness.

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 (1-800-222-1222).

Directions

• do not crush, chew, or break extended-release tablet
• take with a full glass of water
• this product can be administered without regard for the timing of meals
• adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
• children under 12 years of age: do not use

Other information

• store at 20-25°C (68-77°F)

Inactive ingredients

carbomer homopolymer type B, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate,

microcrystalline cellulose, sodium starch glycolate

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

LEADER™

Mucus Relief

Guaifenesin, 600 mg

Extended-Release Tablets

Expectorant

12-Hour

Relieves Chest Congestion

Thins and Loosens Mucus

Immediate and Extended Release

Actual Size

COMPARE TO MUCINEX® active ingredient

100% Money Back Guarantee

20 EXTENDED-RELEASE TABLETS

INGREDIENTS AND APPEARANCE

LEADER MUCUS RELIEF 
guaifenesin tablet, multilayer, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0758
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	600 mg

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	L2X2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0758-1	1 in 1 CARTON	04/08/2026
1		20 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078912	04/08/2026

Labeler - Cardinal Health 110, LLC. dba Leader (063997360)