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NDC 69842-0732-42 Mucus Relief Extended Release 1200 mg/1 Details

Mucus Relief Extended Release 1200 mg/1

Mucus Relief Extended Release is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy. 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: 69842-0732-42
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	69842-0732
Product ID	69842-732_04b72517-4fa1-4bdf-a254-a582c6d5e542
Associated GPIs
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 Extended Release
Proprietary Name Suffix	Maximum Strength
Non-Proprietary Name	Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	1200
Active Ingredient Units	mg/1
Substance Name	GUAIFENESIN
Labeler Name	CVS Pharmacy
Pharmaceutical Class	Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA207342
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69842-0732-42 (69842073242)

Pricing Information	N/A
NDC Package Code	69842-732-42
Billing NDC	69842073242
Package	42 BLISTER PACK in 1 CARTON (69842-732-42) / 1 TABLET in 1 BLISTER PACK
Marketing Start Date	2019-02-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 34314503-b253-4b44-96ff-a42fe2bb161f Details

Active ingredient (in each extended-release tablet)

Guaifenesin 1200 mg

Purpose

Expectorant

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.

Warnings

Do not use

for children under 12 years of age.

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 lasts more than 7 days, comes back, or 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 (1-800-222-1222).

Directions

do not crush, chew, or break tablet
take with a full glass of water
this product can be administered without regard for the timing of meals
adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
children under 12 years of age: do not use

Other information

store between 20º to 25ºC (68º to 77ºF)

Inactive ingredients

carbomer, colloidal silicon dioxide, FD&C blue #1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Maximum Strength Mucinex®*

MAXIMUM STRENGTH

Mucus Extended Release

GUAIFENESIN EXTENDED-RELEASE TABLETS, 1200 mg

EXPECTORANT

Relieves chest congestion
Thins and loosens mucus

EXTENDED-RELEASE TABLETS

*This product is not manufactured or distributed by Reckitt Benckiser LLC, distributor of Maximum Strength Mucinex®.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

Package Label

CVS HEALTH Maximum Strength Mucus Extended Release

INGREDIENTS AND APPEARANCE

MUCUS RELIEF EXTENDED RELEASE MAXIMUM STRENGTH

guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-732
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	1200 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CARBOMER 934 (UNII: Z135WT9208)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	AN037
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69842-732-14	14 in 1 CARTON	02/28/2019
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:69842-732-28	28 in 1 CARTON	02/28/2019
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:69842-732-42	42 in 1 CARTON	02/28/2019
3		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA207342	02/28/2019

Labeler - CVS Pharmacy (062312574)

Revised: 11/2022

Document Id: 04b72517-4fa1-4bdf-a254-a582c6d5e542

Set id: 34314503-b253-4b44-96ff-a42fe2bb161f

Version: 4

Effective Time: 20221122