GUAIFENESIN 600 MG- guaifenesin  tablet, extended release 
GUAIFENESIN 1200 MG- guaifenesin tablet, extended release 
Dr. Reddy's Laboratories Inc.

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Drug Facts

Active ingredient(s)

Guaifenesin 600 mg (for 600mg)

Guaifenesin 1200 mg (for 1200 mg)

Purpose

Expectorant

Use(s)

Warnings

Applicable warning(s) in 201.66(c)(5)(i) and (ii)

Do not use

  • For children under 12 years age

Ask a doctor before use if

  • 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 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 Pregnancy/Breastfeeding,

ask a health professional before use.

Keep out of reach of children

In case of overdose, get medical help or contact aPoison Control Center right away (1-800-222-1222).

Directions

Other information

Inactive ingredients

carbomer homopolymer type B, colloidal silicon dioxide, ferric oxide red, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate type A

Questions?

call 1-888-375-3784 Weekdays (9am - 8pm EST)

You may also report side effects to this phone number.

Distributed by:

Dr. Reddy’s Laboratories, Inc.

Princeton, NJ 08540

Made in India

I 0721

Principal Display Panel- 600mg Carton

Guaifenesin Extended-Release Tablets 600 mg Carton Label

600mgCarton

Principal Display Panel - 1200 mg Carton

Guaifenesin Extended-Release Tablets 1200 mg Carton Label

1200mgcarton

GUAIFENESIN 600 MG 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43598-110(NDC:43598-008)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin600 mg
Inactive Ingredients
Ingredient NameStrength
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked) (UNII: HHT01ZNK31)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Ferric Oxide Red (UNII: 1K09F3G675)  
Hydroxypropyl Cellulose (110000 Wamw) (UNII: 5Y0974F5PW)  
Hypromellose 2910 (10000 Mpa.S) (UNII: 0HO1H52958)  
Hypromellose 2208 (4000 Mpa.S) (UNII: 39J80LT57T)  
Magnesium Stearate (UNII: 70097M6I30)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)  
Product Characteristics
ColorPINK (White on debossed side and Light Pink to Pink on other side ) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code 6
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43598-110-015 in 1 CARTON09/01/2022
120 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21593209/01/2022
GUAIFENESIN 1200 MG 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43598-108(NDC:43598-009)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin1200 mg
Inactive Ingredients
Ingredient NameStrength
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked) (UNII: HHT01ZNK31)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Ferric Oxide Red (UNII: 1K09F3G675)  
Hydroxypropyl Cellulose (110000 Wamw) (UNII: 5Y0974F5PW)  
Hypromellose 2910 (10000 Mpa.S) (UNII: 0HO1H52958)  
Hypromellose 2208 (4000 Mpa.S) (UNII: 39J80LT57T)  
Magnesium Stearate (UNII: 70097M6I30)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)  
Product Characteristics
ColorPINK (White on debossed side and Light Pink to Pink on other side ) Scoreno score
ShapeOVALSize22mm
FlavorImprint Code 12
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43598-108-373 in 1 CARTON09/01/2022
114 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21593209/01/2022
Labeler - Dr. Reddy's Laboratories Inc. (802315887)

Revised: 6/2022
Document Id: aef9a93b-9bb3-7b51-f163-14c2469872cf
Set id: 525fda90-134c-f038-c403-eb5ffc1fb1f1
Version: 2
Effective Time: 20220615
 
Dr. Reddy's Laboratories Inc.