MUCUS RELIEF- guaifenesin tablet

MUCUS RELIEF by

Drug Labeling and Warnings

MUCUS RELIEF by is a Otc medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Guaifenesin 400 mg

Purpose

Expectorant

Uses

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

Warnings

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)

Stop use and ask a doctor if

• cough lasts more than 7 days or comes back
  
• cough 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.

Directions

• take with full glass of water
  
• do not exceed recommended dose

• adults and children 12 years of age and over: 1 tablet, every 4 hours, while ; symptoms persist do not ; exceed 6 doses in 24 hours
• children under 12 years of age: do not use

Other information

Tamper Evident: do not use if imprinted safety seal under cap is broken or missing.

store at controlled room temperature 20 °-25°C (68°-77°F)

Inactive ingredients

cellulose, magnesium stearate, maltodextrin, povidone, silica, sodium starch glycolate, stearic acid.

HOW SUPPLIED

Product: 71335-1035

NDC: 71335-1035-1 30 TABLET in a BOTTLE

NDC: 71335-1035-2 20 TABLET in a BOTTLE

NDC: 71335-1035-3 50 TABLET in a BOTTLE

NDC: 71335-1035-4 60 TABLET in a BOTTLE

NDC: 71335-1035-5 40 TABLET in a BOTTLE

MUCUS RELIEF (GUAIFENESIN) TABLET

INGREDIENTS AND APPEARANCE

MUCUS RELIEF 
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71335-1035(NDC:57896-794)
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
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	TCL272
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71335-1035-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/05/2019
2	NDC: 71335-1035-4	60 in 1 BOTTLE; Type 0: Not a Combination Product	01/05/2019
3	NDC: 71335-1035-2	20 in 1 BOTTLE; Type 0: Not a Combination Product	01/05/2019
4	NDC: 71335-1035-5	40 in 1 BOTTLE; Type 0: Not a Combination Product	01/05/2019
5	NDC: 71335-1035-3	50 in 1 BOTTLE; Type 0: Not a Combination Product	01/05/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/01/2004

Labeler - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(71335-1035) , RELABEL(71335-1035)