GUAIFENESIN - guaifenesin tablet, extended release 
WALGREEN CO.

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Drug Facts

Active ingredient

(in each extended-release tablet)

Guaifenesin USP 1200 mg

Purpose

Expectorant

Uses


Warnings


Do not use

Ask a doctor before use if you have


Stop use and ask a doctor if


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

Other information

Inactive ingredients


colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinised starch (maize)

Questions?

1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) You may also report side effects to this phone number.

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com
©2021 Walgreen Co.


MADE IN INDIA

Code: AP/DRUGS/04/2016

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg 14 (1 x 14) Tablets

NDC 0363-0033-01
Walgreens

Compare to the active ingredient
in Mucinex®MaximumStrength††

WALGREENS
PHARMACIST RECOMMENDED

12 HOUR
Mucus
Relief ER
GUAIFENESIN EXTENDED-RELEASE
TABLETS, 1200 mg /
EXPECTORANT

Maximum Strength           12 Hour


14                                                 69
EXTENDED-
RELEASE                         ACTUAL SIZE
TABLETS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg (20 Tablet Label) 


GUAIFENESIN 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0033
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)  
HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
POVIDONE K25 (UNII: K0KQV10C35)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeOVALSize21mm
FlavorImprint Code L;69
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0033-011 in 1 CARTON05/08/2020
114 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0363-0033-022 in 1 CARTON05/08/2020
214 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0363-0033-033 in 1 CARTON04/01/2021
314 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21045305/08/2020
Labeler - WALGREEN CO. (008965063)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650918514ANALYSIS(0363-0033) , MANUFACTURE(0363-0033)

Revised: 12/2023
Document Id: 444d342a-dfc8-44ac-9be0-1e85b419d293
Set id: 0c329d9f-8f1e-4b41-a03b-324e5d1b4ae2
Version: 6
Effective Time: 20231201
 
WALGREEN CO.