MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 MG- guaifenesin tablet

MUCUS RELIEF by

Drug Labeling and Warnings

MUCUS RELIEF by is a Otc medication manufactured, distributed, or labeled by TWIN MED LLC. Drug facts, warnings, and ingredients follow.

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

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

• do not crush, chew, or break 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 between 20° to 25°C (68° to 77°F)

Inactive ingredients

carbomer homopolymer type B, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

Questions?

call toll-free 1-800-935-6737

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MUCUS RELIEF  GUAIFENESIN EXTENDED-RELEASE 600 MG
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55681-301
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
MAGNESIUM STEARATE (UNII: 70097M6I30)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	G;600
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55681-301-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/02/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA213420	03/02/2022

Labeler - TWIN MED LLC (009579330)