GUAIFENESIN - guaifenesin tablet, extended release 
Family Dollar, Inc.

----------

Drug Facts

Active ingredients

(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:
MIDWOOD BRANDS, LLC
500 VOLVO PARKWAY, CHESAPEAKE,
VA 23320

Code: AP/DRUGS/04/2016

Made in India

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton (7 (1 x 7) Tablets)

COMPARE TO THE ACTIVE INGREDIENT
IN MAXIMUM STRENGTH MUCINEX®*

NDC 55319-902-64

FAMILY
Wellness

MAXIMUM STRENGTH
Mucus Relief
GUAIFENESIN EXTENDED-RELEASE TABLETS
1200 mg, EXPECTORANT


12                                69
HOUR                 ACTUAL SIZE

√    RELIEVES CHEST CONGESTION

    THINS AND LOOSENS MUCUS

7 EXTENDED-RELEASE TABLETS


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton (7 (1 x 7) Tablets)
GUAIFENESIN 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-902
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:55319-902-641 in 1 CARTON09/22/202010/31/2022
17 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21045309/22/202010/31/2022
Labeler - Family Dollar, Inc. (024472631)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650918514ANALYSIS(55319-902) , MANUFACTURE(55319-902)

Revised: 10/2022
 
Family Dollar, Inc.