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NDC 30142-0961-20 GUAIFENESIN 600 mg/1 Details

GUAIFENESIN 600 mg/1

GUAIFENESIN is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Kroger Company. 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: 30142-0961-20
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	30142-0961
Product ID	30142-961_5b667b46-235a-4d9c-aea1-0ec8286e3bbc
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	GUAIFENESIN
Proprietary Name Suffix	n/a
Non-Proprietary Name	Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	600
Active Ingredient Units	mg/1
Substance Name	GUAIFENESIN
Labeler Name	Kroger Company
Pharmaceutical Class	Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA209254
Listing Certified Through	2024-12-31

Package

Package Images

NDC 30142-0961-20 (30142096120)

Pricing Information	N/A
NDC Package Code	30142-961-20
Billing NDC	30142096120
Package	1 BLISTER PACK in 1 CARTON (30142-961-20) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date	2022-04-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d1ffd899-2a2a-41c0-b0c0-7c42f8cabf8d Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each extended-release tablet)

Guaifenesin USP 600 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.

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 extended-release 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: one or two extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours.
children under 12 years of age: do not use

Other information

store between 20-25°C (68-77°F)
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR IF PRINTED SEAL ON BLISTER IS BROKEN OR MISSING.

Inactive ingredients

colloidal silicon dioxide, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, povidone.

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

PRINCIPAL DISPLAY PANEL - 20 Tablets Blister Pack Carton

COMPARE TO the active ingredient of

Mucinex®

NDC 30142-961-20

Kroger®

OUR PHARMACIST RECOMMENDED

Mucus

Relief ER

Guaifenesin 600 mg

Extended-Release

Tablets,

EXPECTORANT

12 HOUR

Relieves Chest Congestion
Thins & Loosens Mucus

20 EXTENDED-RELEASE

TABLETS

PRINCIPAL DISPLAY PANEL - 20 Tablets Blister Pack Carton

INGREDIENTS AND APPEARANCE

GUAIFENESIN

guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:30142-961
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	600 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	RH98
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:30142-961-20	1 in 1 CARTON	04/28/2022
1		20 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	ANDA209254	04/28/2022

Labeler - Kroger Company (006999528)

Name	Address	ID/FEI	Business Operations
Establishment
Ohm Laboratories Inc.		184769029	MANUFACTURE(30142-961)

Revised: 4/2022

Document Id: 5b667b46-235a-4d9c-aea1-0ec8286e3bbc

Set id: d1ffd899-2a2a-41c0-b0c0-7c42f8cabf8d

Version: 3

Effective Time: 20220429

Search by Drug Name or NDC

NDC 30142-0961-20 GUAIFENESIN 600 mg/1 Details

GUAIFENESIN 600 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 30142-0961-20 (30142096120)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL d1ffd899-2a2a-41c0-b0c0-7c42f8cabf8d Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each extended-release tablet)

Purpose

Uses

Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 20 Tablets Blister Pack Carton

INGREDIENTS AND APPEARANCE

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