Search by Drug Name or NDC

NDC 63629-8348-01 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 Bryant Ranch Prepack. 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: 63629-8348-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	63629-8348
Product ID	63629-8348_eeea46d1-deb2-4381-a5dd-0a0fbd248398
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	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	Bryant Ranch Prepack
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 63629-8348-01 (63629834801)

Pricing Information	N/A
NDC Package Code	63629-8348-1
Billing NDC	63629834801
Package	28 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8348-1)
Marketing Start Date	2020-09-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL eeea46d1-deb2-4381-a5dd-0a0fbd248398 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.

HOW SUPPLIED

NDC: 63629-8348-1: 28 Tablets in a BOTTLE

NDC: 63629-8348-2: 180 Tablets in a BOTTLE

PRINCIPAL DISPLAY PANEL

Guaifenesin ER 1200mg Tablet

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH MUCUS RELIEF

guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63629-8348(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:63629-8348-1	28 in 1 BOTTLE; Type 0: Not a Combination Product	09/02/2020
2	NDC:63629-8348-2	180 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA209215	11/06/2019

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(63629-8348) , RELABEL(63629-8348)

Revised: 2/2022

Document Id: eeea46d1-deb2-4381-a5dd-0a0fbd248398

Set id: eeea46d1-deb2-4381-a5dd-0a0fbd248398

Version: 2

Effective Time: 20220209