OTC Medication Information: Mucinex

MUCINEX- guaifenesin tablet, extended release
Proficient Rx LP

Drug Facts

Active ingredient (in each extended-release bi-layer tablet)

Guaifenesin 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.

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 or 2 tablets every 12 hours. Do not exceed 4 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 20-25°C (68-77°F)

Inactive ingredients

carbomer homopolymer type B; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Questions?

1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.

Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224

Relabeled by: Proficient Rx LP
Thousand Oaks, CA 91320

Made in England

PRINCIPAL DISPLAY PANEL — 40 Tablet Carton

NDC 63187-954-20

Mucinex ®
600 mg guaifenesin
extended-release bi-layer tablets
EXPECTORANT

12
HOUR

Relieves Chest Congestion
Thins and Loosens Mucus
Immediate and Extended Release

20
EXTENDED-RELEASE
BI-LAYER TABLETS

63187-954-20
(click image for full-size original)
MUCINEX
guaifenesin tablet, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-954(NDC:63824-008)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Guaifenesin (Guaifenesin) Guaifenesin 600 mg
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
FD&C BLUE NO. 1
ALUMINUM OXIDE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE (blue and white) Score no score
Shape OVAL Size 16mm
Flavor Imprint Code Mucinex;600
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63187-954-20 20 TABLET, EXTENDED RELEASE in 1 CARTON None
2 NDC:63187-954-40 40 TABLET, EXTENDED RELEASE in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021282 07/03/2012
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 RELABEL (63187-954)

Revised: 01/2021 Proficient Rx LP

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2023. All Rights Reserved.