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NDC 69230-0315-31 Maximum Strength Mucus Relief 1200 mg/1 Details

Maximum Strength Mucus Relief 1200 mg/1

Maximum Strength Mucus Relief is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Camber Consumer Care. 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: 69230-0315-31
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	69230-0315
Product ID	69230-315_bb6801c3-e110-4497-9dbd-b760ff99c255
Associated GPIs	43200010007450
GCN Sequence Number	063103
GCN Sequence Number Description	guaifenesin TAB ER 12H 1200 MG ORAL
HIC3	B3J
HIC3 Description	EXPECTORANTS
GCN	98863
HICL Sequence Number	000271
HICL Sequence Number Description	GUAIFENESIN
Brand/Generic	Generic
Proprietary Name	Maximum Strength Mucus Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	1200
Active Ingredient Units	mg/1
Substance Name	GUAIFENESIN
Labeler Name	Camber Consumer Care
Pharmaceutical Class	Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA209215
Listing Certified Through	2023-12-31

Package

Package Images

NDC 69230-0315-31 (69230031531)

Pricing Information
NDC Package Code	69230-315-31
Billing NDC	69230031531
Package	2 BLISTER PACK in 1 CARTON (69230-315-31) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date	2019-11-06
NDC Exclude Flag	N
Price Per Unit	0.46903
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	MUCUS RELIEF ER 1,200 MG TAB
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 5d66abab-907f-404a-91ed-ec8f21721d68 Details

ACTIVE INGREDIENT(in each extended-release tablet)

Guaifenesin 1200 mg

PURPOSE

Expectorant

USE(S)

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

WARNING

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

tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
store between 20 to 25°C (68 to 77°F)

INACTIVE INGREDIENT SECTION

carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

QUESTIONS?

1-609-860-2600

Hours: 8am - 4pm, EST

You may also report side effects to this phone number.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAMBER CONSUMER CARE

Maximum Strength Mucus Relief

NDC 69230-315-31

Compare to the active ingredient in Mucinex® Maximum Strength Extended Release 1200 mg Tablets*

12 HOUR

Maximum Strength Mucus Relief

Guaifenesin Extended-Release

Tablets 1200 mg

Expectorant

Relieves Chest Congestion
Thins and Loosens Mucus

14 EXTENDED-RELEASE TABLETS

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH MUCUS RELIEF

guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69230-315
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 CROSSLINKED) (UNII: HHT01ZNK31)
HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	22mm
Flavor		Imprint Code	G234
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69230-315-31	2 in 1 CARTON	11/06/2019
1		7 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:69230-315-32	4 in 1 CARTON	11/06/2019
2		7 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	ANDA209215	11/06/2019

Labeler - Camber Consumer Care (079539968)

Revised: 1/2022

Document Id: bb6801c3-e110-4497-9dbd-b760ff99c255

Set id: 5d66abab-907f-404a-91ed-ec8f21721d68

Version: 2

Effective Time: 20220111