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NDC 68391-0000-45 berkley and jensen mucus relief 1200 mg/1 Details

berkley and jensen mucus relief 1200 mg/1

berkley and jensen mucus relief is a ORAL TABLET, MULTILAYER, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by BJWC. 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: 68391-0000-45
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	68391-0000
Product ID	68391-000_6792a293-6488-4eb4-adb6-0d8dbe93d4fc
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	berkley and jensen mucus relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, MULTILAYER, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	1200
Active Ingredient Units	mg/1
Substance Name	GUAIFENESIN
Labeler Name	BJWC
Pharmaceutical Class	Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA213420
Listing Certified Through	2024-12-31

Package

Package Images

NDC 68391-0000-45 (68391000045)

Pricing Information	N/A
NDC Package Code	68391-000-45
Billing NDC	68391000045
Package	4 BLISTER PACK in 1 CARTON (68391-000-45) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date	2021-04-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 433588eb-18ad-473f-9527-4947a143824e 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 make 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. hese 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 20°-25°C (68°-77°F)

Inactive ingredients

carbomer homopolymer type B, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

1-800-934-1204

Package/Label Principal Display Panel

Compare to the active ingredient in Maximum Strength Mucinex®

berkley jensen®

MAXIMUM STRENGTH

MUCUS RELIEF

GUAIFENESIN EXTENDED-RELEASE TABLETS, 1200mg

EXPECTORANT

RELIEVES CHEST CONGESTION

THINS AND LOOSENS MUCUS

IMMEDIATE AND EXTENDED RELEASE

12 HOUR

ACTUAL SIZE

56 EXTENDED-RELEASE TABLETS

INGREDIENTS AND APPEARANCE

BERKLEY AND JENSEN MUCUS RELIEF

guaifenesin tablet, multilayer, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68391-000
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
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	G;1200
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68391-000-45	4 in 1 CARTON	04/04/2021
1		14 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	ANDA213420	04/04/2021

Labeler - BJWC (159082692)

Revised: 4/2022

Document Id: 6792a293-6488-4eb4-adb6-0d8dbe93d4fc

Set id: 433588eb-18ad-473f-9527-4947a143824e

Version: 2

Effective Time: 20220419