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NDC 57896-0614-06 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 Geri-Care Pharmaceuticals, Corp. 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: 57896-0614-06
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	57896-0614
Product ID	57896-614_ee13ae41-86e0-12f7-e053-2a95a90a2a13
Associated GPIs	43200010000340
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	MUCUS RELIEF
Proprietary Name Suffix	n/a
Non-Proprietary Name	Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	400
Active Ingredient Units	mg/1
Substance Name	GUAIFENESIN
Labeler Name	Geri-Care Pharmaceuticals, Corp
Pharmaceutical Class	Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	n/a

Package

Package Images

NDC 57896-0614-06 (57896061406)

Pricing Information	N/A
NDC Package Code	57896-614-06
Billing NDC	57896061406
Package	60 TABLET in 1 BOTTLE (57896-614-06)
Marketing Start Date	2021-09-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d218f365-6f48-5639-e053-2995a90a10a9 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 passageways

of bothersome mucus

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)

Stop use and ask a doctor if

cough lasts more than 7 days or comes back
cough occurs with fever, rash or persistent headache

These could be signs of a serious illness.

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

take with full glass of water
do not exceed recommended dose

adults and children 12 years of age and over	1 tablet, every 4 hours, while symptoms persist • do not exceed 6 doses in 24 hours
children under 12 years of age	do not use

Other information

Tamper Evident: do not use if imprinted safety seal under cap is broken or missing.
store at 20°-25°C (68°-77°F); excursions permitted between 15°C- 30°C (59°F - 86°F)

Inactive ingredients

maltodextrin, povidone, silica, stearic acid

Questions or comments?

1-800-540-3765

package Label

INGREDIENTS AND APPEARANCE

MUCUS RELIEF

guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57896-614
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
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (white to off white)	Score	2 pieces
Shape	ROUND	Size	9mm
Flavor		Imprint Code	AG1
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:57896-614-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2021
2	NDC:57896-614-06	60 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	09/01/2021	11/30/2023

Labeler - Geri-Care Pharmaceuticals, Corp (611196254)

Registrant - Geri-Care Pharmaceuticals, Corp (611196254)

Revised: 11/2022

Document Id: ee13ae41-86e0-12f7-e053-2a95a90a2a13

Set id: d218f365-6f48-5639-e053-2995a90a10a9

Version: 2

Effective Time: 20221122