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NDC 71610-0434-18 Guaifenesin 200mg 200 mg/1 Details

Guaifenesin 200mg 200 mg/1

Guaifenesin 200mg is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, LLC. The primary component is GUAIFENESIN.

MedlinePlus Drug Summary

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Related Packages: 71610-0434-18
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	71610-0434
Product ID	71610-434_5dd755ce-6ef4-4341-a8e9-cd7d342442ea
Associated GPIs	43200010000320
GCN Sequence Number	000761
GCN Sequence Number Description	guaifenesin TABLET 200 MG ORAL
HIC3	B3J
HIC3 Description	EXPECTORANTS
GCN	02482
HICL Sequence Number	000271
HICL Sequence Number Description	GUAIFENESIN
Brand/Generic	Generic
Proprietary Name	Guaifenesin 200mg
Proprietary Name Suffix	n/a
Non-Proprietary Name	Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	200
Active Ingredient Units	mg/1
Substance Name	GUAIFENESIN
Labeler Name	Aphena Pharma Solutions - Tennessee, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71610-0434-18 (71610043418)

Pricing Information	N/A
NDC Package Code	71610-434-18
Billing NDC	71610043418
Package	3000 TABLET in 1 BOTTLE (71610-434-18)
Marketing Start Date	2020-06-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 45ac210a-8c54-4469-8e10-e6fe52b89cb5 Details

SPL UNCLASSIFIED SECTION

GUAIFENESIN 200 MG TABLETS

Marlex Pharmaceuticals, Inc.

----------

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

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count	200 mg
3000	71610-434-18

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Cookeville, TN 38506

20200619JH

PRINCIPAL DISPLAY PANEL - 200 mg

NDC 71610-434 - Guaifenesin 200 mg Tablets

INGREDIENTS AND APPEARANCE

GUAIFENESIN 200MG

guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71610-434(NDC:10135-681)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71610-434-18	3000 in 1 BOTTLE; Type 0: Not a Combination Product	06/16/2020

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

Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)

Name	Address	ID/FEI	Business Operations
Establishment
Aphena Pharma Solutions - Tennessee, LLC		128385585	REPACK(71610-434)

Revised: 6/2020

Document Id: 5dd755ce-6ef4-4341-a8e9-cd7d342442ea

Set id: 45ac210a-8c54-4469-8e10-e6fe52b89cb5

Version: 1

Effective Time: 20200619