GUAIFENESIN 200MG- guaifenesin tablet

Guaifenesin 200mg by

Drug Labeling and Warnings

Guaifenesin 200mg 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 200 MG TABLETS

Marlex Pharmaceuticals, Inc.

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Drug Fact

Active ingredient (in each tablet)

Guaifenesin 200mg

Purpose

Expectorant

Guaifenesin 200 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, 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: 10135-0681-01
Guaifenesin
200 mg
100 TABLETS

INGREDIENTS AND APPEARANCE

GUAIFENESIN 200MG 
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10135-681
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
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	ROUND	Size	8mm
Flavor		Imprint Code	G2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10135-681-01	100 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)