GUAIFENESIN AND PSEUDOEPHEDRINE HCL - guaifenesin and pseudoephedrine hcl tablet, extended release 
Aurohealth LLC

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Drug Facts

Active ingredients

(in each extended-release tablet)     

Guaifenesin USP 600 mg                                                                                      

Pseudoephedrine HCl USP 60 mg                                                                        

Purposes

Expectorant

Nasal Decongestant

Uses

Warnings


Ask a doctor before use if you have

When using this product

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, pregelatinised starch (maize).

Questions?

1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India
Code: AP/DRUGS/04/2016

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/60 mg (18 Tablet Carton Label)

AUROHEALTH

NDC 58602-833-12

*Compare to the active
ingredients of Mucinex®D


Guaifenesin and
Pseudoephedrine Hydrochloride
Extended-Release Tablets
600 mg/60 mg


Guaifenesin 600 mg - Expectorant
Pseudoephedrine HCl 60 mg - Nasal Decongestant
RELIEVES NASAL & CHEST CONGESTION

12 HOUR
• Clears Nasal & Sinus Congestion
• Thins & Loosens Mucus

18 Extended-Release Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/60 mg (18 Tablet Carton Label)

GUAIFENESIN AND PSEUDOEPHEDRINE HCL 
guaifenesin and pseudoephedrine hcl tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-833
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
POVIDONE K25 (UNII: K0KQV10C35)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeOVAL (biconvex) Size14mm
FlavorImprint Code 64;X
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-833-121 in 1 CARTON03/25/2020
118 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:58602-833-172 in 1 CARTON03/25/2020
218 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21320303/25/2020
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650918514ANALYSIS(58602-833) , MANUFACTURE(58602-833)

Revised: 9/2024
Document Id: 436b7cb6-bc72-4b51-986e-22ad631ce0a2
Set id: 644dae51-7865-408c-a603-5eddffb90e53
Version: 4
Effective Time: 20240903
 
Aurohealth LLC