GUAIFENESIN - guaifenesin tablet, extended release 
VESPYR BRANDS, INC.

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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)

Inactive ingredients


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

Questions or comments?

call toll-free 1-855-874-0970 (English/Spanish) weekdays. You may also report side effects to this phone number.


DISTRIBUTED BY:
Vespyr Brands®, Inc.
East Windsor, NJ 08520

Made in India

Code: AP/DRUGS/04/2016

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton (21 Tablets)

12                                    NDC 71179-002-21
HR
CONTAC®
CHEST CONGESTION

Guaifenesin
Extended-Release Tablets 1200 mg
Expectorant
Maximum Strength 

  • Relieves Chest Congestion
  • Thins And Loosens Mucus

21 EXTENDED-RELEASE TABLETS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton (21 (1 x 21) Tablets)


GUAIFENESIN 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71179-002
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:71179-002-213 in 1 CARTON06/27/2022
17 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21045306/27/2022
Labeler - VESPYR BRANDS, INC. (118094893)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650918514ANALYSIS(71179-002) , MANUFACTURE(71179-002)

Revised: 6/2022
Document Id: e2e3c628-d241-42b6-8c1e-ef997ffa6e87
Set id: e2e3c628-d241-42b6-8c1e-ef997ffa6e87
Version: 1
Effective Time: 20220627
 
VESPYR BRANDS, INC.