MUCUS RELIEF- guaifenesin 400 mg tablet

Mucus Relief by

Drug Labeling and Warnings

Mucus Relief by is a Otc medication manufactured, distributed, or labeled by Health Pharma USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

Guaifenesin 400 mg

Purpose

Expectorant

Uses

• Temporary symptomatic relief from congested chests and cough.

Warnings

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.

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 excessive phlegm (mucus).

When using this product

• Do not exceed recommended dosage.
• Do not consume alcohol, benzodiazepines or opioids.

Stop use and ask a doctor if

cough lasts for more than 7 days please consult your physician or healthcare provider.

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 (1-800-222-1222) right away.

Directions

• Adults and children 12 years of age and over: take 1 caplet a day.
• Children under 12 years:Do not use.
• Do not exceed 4 doses in 24 hours.

Other information

• Store at 25°C (77°F) excursions between 15°-30°C (59°-86°F).
• Keep in a dry place and do not expose to heat.
• Read all product information before using.
• TEMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

Croscarmellose sodium, Maltodextrin, PVP K30, Silicon dioxide, Microcrystalline cellulose, Stearic acid, Purified water.

Questions or comments?

Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST

Principal Display Panel-60 count

Principal Display Panel-200 count

INGREDIENTS AND APPEARANCE

MUCUS RELIEF 
guaifenesin 400 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71679-119
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg

Inactive Ingredients
Ingredient Name	Strength
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POVIDONE K30 (UNII: U725QWY32X)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	G400
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71679-119-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2025
2	NDC: 71679-119-02	200 in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/18/2025

Labeler - Health Pharma USA LLC (080804485)

Registrant - Health Pharma USA LLC (080804485)

Establishment
Name	Address	ID/FEI	Business Operations
ELYSIUM PHARMACEUTICALS LIMITED		915664486	manufacture(71679-119)

Establishment
Name	Address	ID/FEI	Business Operations
HHH PHARMA USA LLC		062788820	pack(71679-119)