GUAIFENESIN - guaifenesin tablet, extended release 
RITE AID CORPORATION

----------

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:RITE AID,
30 HUNTER LANE, CAMP HILL,
PA 17011   www.riteaid.com

MADE IN INDIA

Code: AP/DRUGS/04/2016

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

Compare to the active Ingredient in Maximum Strength Mucinex®*

NDC 11822-4260-1


MAXIMUM STRENGTH
MUCUS
RELIEF
GUAIFENESIN EXTENDED-RELEASE
TABLETS 1200 mg  
EXPECTORANT

Relieves chest congestion
Thins & loosens mucus

12
HOUR                  ACTUAL SIZE


14
EXTENDED-RELEASE
TABLETS

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

GUAIFENESIN 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-4260
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:11822-4260-11 in 1 CARTON06/29/2022
114 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:11822-4260-22 in 1 CARTON06/29/2022
214 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:11822-4260-33 in 1 CARTON06/29/2022
314 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21045306/29/2022
Labeler - RITE AID CORPORATION (014578892)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650918514ANALYSIS(11822-4260) , MANUFACTURE(11822-4260)

Revised: 12/2023
Document Id: afdc12f3-6003-4da4-a148-2c7350e3b178
Set id: de16ec42-4a31-4b18-e053-2995a90a78a4
Version: 3
Effective Time: 20231201
 
RITE AID CORPORATION