GUAIFENESIN AND PSEUDOEPHEDRINE HCL- guaifenesin and pseudoephedrine hcl tablet, extended release 
Granules India Ltd

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Guaifenesin and Pseudoephedrine HCl Extended-Release Tablets, 600 mg/60 mg and 1200 mg/120 mg

Drug Facts

Active ingredients (in each extended-release tablet)

(For 600 mg/60 mg)

Guaifenesin USP, 600 mg

Pseudoephedrine HCL USP, 60 mg


(For 1200 mg/120 mg)


Guaifenesin USP, 1200 mg
Pseudoephedrine HCL USP, 120 mg

Purposes

Expectorant

Nasal Decongestant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

• temporarily relieves nasal congestion due to:
• common cold
• hay fever
• upper respiratory allergies

• temporarily restores freer breathing through the nose

• promotes nasal and/or sinus drainage

• temporarily relieves sinus congestion and pressure

Warnings

 Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• heart disease

• high blood pressure

• thyroid disease

• diabetes

• trouble urinating due to an enlarged prostate gland

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

• cough accompanied by too much phlegm (mucus)

When using this product

• do not use more than directed

Stop use and ask a doctor if

• you get nervous, dizzy, or sleepless

• symptoms do not get better within 7 days, come back or occur with a 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 Centre right away (1-800 222-1222).

Directions

• do not crush, chew, or break extended-release tablet

• take with a full glass of water

• this product can be administered without regard for timing of meals

• adults and children 12 years and older:

For 600 mg/60 mg: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours

For 1200 mg/120 mg: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours

• children under 12 years of age: do not use

Other information

• Tamper evident: do not use if carton is open or if printed seal on blister is broken or missing.

• store between 20-25°C (68-77°F)

Inactive ingredients

carbomer homopolymer Type B, cellulose microcrystalline, hypromellose, lake of FD&C yellow 6, magnesium stearate, sodium starch glycolate Type A

Questions or comments?

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

You may also report side effects to this phone number.

Keep the carton.
It contains important information. See end panel for expiration date.


Manufactured By:
Granules India Limited
Hyderabad – 500 081, INDIA

MADE IN INDIA

Distributed By:
Granules USA, Inc.
Parsippany, NJ 07054

PRINCIPAL DISPLAY PANEL 600 mg and 60 mg - Blister Foil Label

ggf-pseudo-600mg-60mg-foil-label

PRINCIPAL DISPLAY PANEL 600 mg and 60 mg - Blister Carton Label

NDC 62207-827-72Compare To
the active ingredients of
Mucinex ® D

Guaifenesin and
Pseudoephedrine Hydrochloride
FOR DAY OR NIGHT

Extended-Release Tablets12HR

600 mg and 60 mg

Guaifenesin 600 mg - Expectorant • Clears Nasal & Sinus Congestion
Pseudoephedrine HCl
60 mg - Nasal Decongestant • Thins & Loosens Mucus
• Immediate & Extended Release

RELIEVES NASAL & CHEST CONGESTION


90 (9x10) Extended-Release Tablets

ggf-pseudo-600mg-60mg-blistercarton

PRINCIPAL DISPLAY PANEL 1200 mg and 120 mg - Blister Foil Label

ggf-pseudo-1200mg-120mg-foil-label

PRINCIPAL DISPLAY PANEL 1200 mg and 120 mg - Blister Carton Label

NDC 62207-828-71Compare To
the active ingredients of
Mucinex ® D

Guaifenesin and
Pseudoephedrine Hydrochloride
FOR DAY OR NIGHT
Extended-Release Tablets12HR

1200 mg and 120 mg

Guaifenesin 1200 mg - Expectorant • Clears Nasal & Sinus Congestion
Pseudoephedrine HCl 120 mg - Nasal Decongestant • Thins & Loosens Mucus
• Immediate & Extended Release

RELIEVES NASAL & CHEST CONGESTION


70 (7x10) Extended-Release Tablets

ggf-pseudo-1200mg-120mg-blistercarton

GUAIFENESIN AND PSEUDOEPHEDRINE HCL 
guaifenesin and pseudoephedrine hcl tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-827
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
MAGNESIUM STEARATE (UNII: 70097M6I30)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)  
Product Characteristics
Colororange (Light orange and orange colored) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code GP;600
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-827-729 in 1 CARTON06/01/2023
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21608206/01/2023
GUAIFENESIN AND PSEUDOEPHEDRINE HCL 
guaifenesin and pseudoephedrine hcl tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-828
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)  
Product Characteristics
Colororange (Light orange and orange colored) Scoreno score
ShapeOVALSize22mm
FlavorImprint Code GP;1200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-828-717 in 1 CARTON06/01/2023
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21608206/01/2023
Labeler - Granules India Ltd (915000087)

Revised: 10/2024
Document Id: 247ebc5d-3382-028e-e063-6394a90aabf3
Set id: 75f4ff44-02e7-4a23-a394-85fe8b442e1a
Version: 3
Effective Time: 20241018
 
Granules India Ltd