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NDC 71610-0098-18 Mucus Relief 200 mg/1 Details

Mucus Relief 200 mg/1

Mucus Relief 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: 71610-0098-18
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	71610-0098
Product ID	71610-098_34de35ef-20f0-4707-9f11-dcf8c4040796
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	Mucus Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Guaifenesin 200 mg
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 71610-0098-18 (71610009818)

Pricing Information	N/A
NDC Package Code	71610-098-18
Billing NDC	71610009818
Package	3000 TABLET in 1 BOTTLE (71610-098-18)
Marketing Start Date	2018-07-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2ae3c1e1-2a12-444d-a763-590320d373e1 Details

Active ingredient (in each tablet)

Guaifenesin 200 mg

Purpose

Expectorant

Uses

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

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away.

IN CASE OF PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

stop use and ask a doctor

if cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache.These could be signs of serious illness

Directions:

adults and children 12 years of age and over: take 1 to 2 tablets every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
children under 12 years: do not use

OTHER INFORMATION

store at 15°-30°C (59°-86°F)
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

colloidal silicon dioxide, FD&C RED#40(Al-lake), magnesium stearate, maltodextrin, microcrystalline cellulose, stearic acid, sodium starch glycolate

Questions or Comments

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

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

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	71610-098-18

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

20180718JH

PRINCIPAL DISPLAY PANEL - 200 mg

NDC 71610-098 - Guaifenesin 200 mg - Rx Only

INGREDIENTS AND APPEARANCE

MUCUS RELIEF

guaifenesin 200 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71610-098(NDC:54738-980)
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
FD&C RED NO. 40 (UNII: WZB9127XOA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	red	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	AP;151
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71610-098-18	3000 in 1 BOTTLE; Type 0: Not a Combination Product	07/16/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	03/01/2016

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

Name	Address	ID/FEI	Business Operations
Establishment
Aphena Pharma Solutions - Tennessee, LLC		128385585	REPACK(71610-098)

Revised: 7/2018

Document Id: 34de35ef-20f0-4707-9f11-dcf8c4040796

Set id: 2ae3c1e1-2a12-444d-a763-590320d373e1

Version: 2

Effective Time: 20180718