GUAIFENESIN - guaifenesin tablet, extended release 
WALGREEN CO.

----------

Drug Facts

Active ingredient

(in each extended-release tablet)

Guaifenesin USP 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

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° to 25°C (68° to 77°F)
  • Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing

Inactive ingredients


colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, 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 ©2019 Walgreen Co.

MADE IN INDIA

Code: AP/DRUGS/04/2016

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

Walgreens

Compare to Mucinex®Maximum
Strength active ingredient††


NDC 0363-0033-01

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

MAXIMUM STRENGTH

12 HOUR

  • Relieves chest congestion
  • Thins and loosens mucus

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
Aurobindo Pharma Limited650918514ANALYSIS(0363-0033) , MANUFACTURE(0363-0033)

Revised: 4/2021
 
WALGREEN CO.