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NDC 63868-0148-14 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 CHAIN DRUG MARKETING ASSOCIATION INC. 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: 63868-0148-14
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	63868-0148
Product ID	63868-148_d0718695-5405-db6a-e053-2995a90ac591
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	CHAIN DRUG MARKETING ASSOCIATION INC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA213420
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63868-0148-14 (63868014814)

Pricing Information	N/A
NDC Package Code	63868-148-14
Billing NDC	63868014814
Package	2 BLISTER PACK in 1 CARTON (63868-148-14) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date	2021-09-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c20f64e3-485b-4ea7-b73d-56e5c898ed2e Details

SPL UNCLASSIFIED SECTION

Drug Facts

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

SPL UNCLASSIFIED SECTION

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 20-25ºC (68-77ºF)

■ retain carton for complete product information and warnings

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

QUALITY CHOICE®

NDC 63868-148-14

†Compare to the Active Ingredient in MUCINEX® Maximum Strength

12 Hour

Maximum Strength

Mucus Relief

Expectorant

Guaifenesin Extended-Release Tablets, 1200 mg

• Relieves Chest Congestion

• Thin & Loosens Mucus

• Immediate and Extended Release

Actual Size

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:63868-148
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 SUCROSE CROSSLINKED) (UNII: Z135WT9208)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	white	Score	no score
Shape	OVAL (Elliptical)	Size	22mm
Flavor		Imprint Code	G;1200
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63868-148-14	2 in 1 CARTON	09/17/2021
1		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	ANDA213420	09/17/2021

Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)

Revised: 11/2021

Document Id: d0718695-5405-db6a-e053-2995a90ac591

Set id: c20f64e3-485b-4ea7-b73d-56e5c898ed2e

Version: 2

Effective Time: 20211110

Search by Drug Name or NDC

NDC 63868-0148-14 Maximum Strength Mucus Relief 1200 mg/1 Details

Maximum Strength Mucus Relief 1200 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 63868-0148-14 (63868014814)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL c20f64e3-485b-4ea7-b73d-56e5c898ed2e Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each extended-release tablet)

Purpose

Uses

SPL UNCLASSIFIED SECTION

Directions

Other information

Inactive ingredients

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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