GUAIFENESIN AND DEXTROMETHORPHAN HBR- guaifenesin and dextromethorphan hbr tablet, extended release 
SUN PHARMACEUTICAL INDUSTRIES, INC.

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Drug Facts

Active ingredients (in each extended-release tablet)

Dextromethorphan HBr 60 mg

Guaifenesin 1200 mg

Purposes

Cough suppressant

Expectorant

Uses

•
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
•
temporarily relieves:
•
cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
•
the intensity of coughing
•
the impulse to cough to help you get to sleep

Warnings

Do not use

•
for children under 12 years of age
•
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

•
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

•
cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

Pregnancy or Breast Feeding

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 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: 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

•
Store between 20-25°C (68-77°F)

Inactive ingredients

carbomer homopolymer, colloidal silicon dioxide, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), stearic acid

Package/Label Principal Display Panel

NDC 63304-110-14

Maximum Strength

Guaifenesin & Dextromethorphan HBr Extended-Release Tablets

1200 mg/60 mg

Expectorant & Cough Suppressant

12 Hour

• Controls Cough

• Thins and Loosens Mucus

• Immediate and Extended Release

14 Extended-Release Tablets

SUN PHARMA

spl-guai-dextro-label

Package/Label Principal Display Panel

NDC 63304-106-21

Guaifenesin & Dextromethorphan HBr Extended-Release Tablets

600 mg/30 mg

Expectorant & Cough Suppressant

12 Hour

• Controls Cough

• Thins and Loosens Mucus

• Immediate and Extended Release

20 Extended-Release Tablets

SUN PHARMA

spl-guai-dextro-label2
GUAIFENESIN AND DEXTROMETHORPHAN HBR 
guaifenesin and dextromethorphan hbr tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63304-106
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POVIDONE K30 (UNII: U725QWY32X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITE (off-white) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code 054
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63304-106-211 in 1 CARTON07/01/2021
120 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21478107/01/2021
GUAIFENESIN AND DEXTROMETHORPHAN HBR 
guaifenesin and dextromethorphan hbr tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63304-110
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE60 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POVIDONE K30 (UNII: U725QWY32X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITE (off-white) Scoreno score
ShapeOVALSize22mm
FlavorImprint Code 053
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63304-110-541 in 1 CARTON07/01/2021
114 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21478107/01/2021
Labeler - SUN PHARMACEUTICAL INDUSTRIES, INC. (146974886)
Registrant - SUN PHARMACEUTICAL INDUSTRIES, INC. (146974886)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries Limited650456002MANUFACTURE(63304-110, 63304-106)

Revised: 12/2022
Document Id: 801949ca-1baf-4a19-8466-91b4269a2c63
Set id: 06328741-03e3-49cf-ae44-d4c2116e38a3
Version: 7
Effective Time: 20221206
 
SUN PHARMACEUTICAL INDUSTRIES, INC.