GUAIFENESIN 200MG- guaifenesin tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)
Available from:
Marlex Pharmaceuticals Inc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Expectorant Guaifenesin 200 mg Tablets helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive
Authorization status:
OTC monograph final
Authorization number:
10135-681-01

GUAIFENESIN 200MG- guaifenesin tablet

Marlex Pharmaceuticals Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Guaifenesin 200mg

GUAIFENESIN 200 MG TABLETS

Marlex Pharmaceuticals, Inc.

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Drug Fact

Active ingredient (in each tablet)

Guaifenesin 200mg

Purpos e

Expectorant

Guaifenesin 200 mg Tablets

Us es

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

GUAIFENESIN 200MG

guaifenesin tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:10 135-6 8 1

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

GUAIFENESIN (UNII: 49 5W7451VQ) (GUAIFENESIN - UNII:49 5W7451VQ)

GUAIFENESIN

20 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

ROUND

S iz e

8 mm

Flavor

Imprint Code

Contains

Packag ing

Marlex Pharmaceuticals Inc

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:10 135-6 8 1-0 1

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt341

0 3/0 1/20 19

Labeler -

Marlex Pharmaceuticals Inc (782540215)

Revised: 3/2019

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