GUAIFENESIN 400MG- guaifenesin tablet

Guaifenesin 400mg by

Drug Labeling and Warnings

Guaifenesin 400mg by is a Otc medication manufactured, distributed, or labeled by Marlex Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

GUAIFENESIN 400MG TABLETS

Marlex Pharmaceuticals, Inc.

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Drug Fact

Active ingredient (in each tablet)

Guaifenesin 400mg

Purpose

Expectorant

Guaifenesin 400 mg Tablets

Uses

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

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 too much phlegm (mucus)

Stop use and ask a doctor if

cough last more than 7 days, come back or is accompanied by fever, rash, or persistent headache. There could be signs of a serious illness. 

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

 

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:

• Do not take more than 6 doses in any 24-hour period.
  
• This product is not intended for use in children under 12 years of age
  
• Adults & children 12 years and over: 1 to 2 tablets every 4 hours
  
• Children under 12 years: do not use

Other Information:

• Store at 15°C-30°C (59°F-86°F)

Inactive Ingredients:

Colloidal silicon dioxide, FD&C RED #40(AI-lake), magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid

Manufactured for & Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev: 02/19TCL

PRINCIPAL DISPLAY PANEL

NDC: 10135-0682-30
Guaifenesin
400 mg
30 CAPLETS

PRINCIPAL DISPLAY PANEL

NDC: 10135-0682-60
Guaifenesin
400 mg
60 CAPLETS

INGREDIENTS AND APPEARANCE

GUAIFENESIN 400MG 
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10135-682
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE (Caplet)	Size	10mm
Flavor		Imprint Code	G400
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10135-682-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2019
2	NDC: 10135-682-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/01/2019

Labeler - Marlex Pharmaceuticals Inc (782540215)