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NDC 54738-0981-60 Mucus Relief 400 mg/1 Details

Mucus Relief 400 mg/1

Mucus Relief is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Richmond Pharmaceuticals, Inc.. 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: 54738-0981-60
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	54738-0981
Product ID	54738-981_5cc3bf1b-4684-6a53-e053-2a91aa0abfa6
Associated GPIs	43200010000340
GCN Sequence Number	051583
GCN Sequence Number Description	guaifenesin TABLET 400 MG ORAL
HIC3	B3J
HIC3 Description	EXPECTORANTS
GCN	18906
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 400 mg
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	400
Active Ingredient Units	mg/1
Substance Name	GUAIFENESIN
Labeler Name	Richmond Pharmaceuticals, Inc.
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 54738-0981-60 (54738098160)

Pricing Information	N/A
NDC Package Code	54738-981-60
Billing NDC	54738098160
Package	60 TABLET in 1 BOTTLE (54738-981-60)
Marketing Start Date	2016-03-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 26924bee-32cc-4499-beb0-2650ff8eb1da Details

Active ingredient (in each tablet)

Guaifenesin 400 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 tablet 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, 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

PRINCIPAL DISPLAY PANEL

Guaifenesin 400 mg...Expectorant

NDC- 54738-981-30... 30 CAPLETS

NDC- 54738-981-60... 60 CAPLETS

INGREDIENTS AND APPEARANCE

MUCUS RELIEF

guaifenesin 400 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54738-981
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg

Ingredient Name	Strength
Inactive Ingredients
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	white	Score	2 pieces
Shape	OVAL	Size	17mm
Flavor		Imprint Code	AP;152
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:54738-981-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2016
2	NDC:54738-981-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2016

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

Labeler - Richmond Pharmaceuticals, Inc. (043569607)

Registrant - Advance Pharmaceutical Inc. (078301063)

Name	Address	ID/FEI	Business Operations
Establishment
Advance Pharmaceutical Inc.		078301063	manufacture(54738-981)

Revised: 10/2017

Document Id: 5cc3bf1b-4684-6a53-e053-2a91aa0abfa6

Set id: 26924bee-32cc-4499-beb0-2650ff8eb1da

Version: 2

Effective Time: 20171030