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 and 60 mg; 1200 mg and 120 mg



Drug Facts

ACTIVE INGREDIENS

(in each extended-release tablet)

Guaifenesin USP, 600 mg

Pseudoephedrine HCL USP, 60 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 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 600mg and 60mg: 2 tablets every 12 hours; not more than 4 tablets in 24 hours

For 1200mg and 120mg: 1 tablet every 12 hours; not more than 2 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

1200-120-mg-foil1200-120-mg-carton600-60-mg-foil600-60-mg-carton

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
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
Labeler - Granules India Ltd (915000087)

Revised: 1/2023
Document Id: f33af289-9086-0b0e-e053-2a95a90aa7b8
Set id: 75f4ff44-02e7-4a23-a394-85fe8b442e1a
Version: 2
Effective Time: 20230127
 
Granules India Ltd