GUAIFENESIN AND DEXTROMETHORPHAN HBR- guaifenesin and dextromethorphan hbr tablet, extended release 
Dr. Reddy's Laboratories Inc.

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Drug Facts

Active ingredients

(in each extended-release tablet)

Guaifenesin USP, 600 mg

Dextromethorphan Hydrobromide USP, 30 mg

Guaifenesin USP, 1200 mg

Dextromethorphan Hydrobromide USP, 60 mg

Purposes

Expectorant

Cough suppressant

Uses

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.

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

For 600 mg/30 mg:

For 1200 mg/60 mg:

Other information

Inactive ingredients

carbomer homopolymer type B, colloidal silicon dioxide, FD & C Blue #1, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

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

Issued: 10/2022

Guaifenesin 600 mg and Dextromethorphan 30 mg Extended-Release Tablets

Carton:

carton1

Guaifenesin 1200 mg and Dextromethorphan 60 mg Extended-Release Tablets

Carton:

carton2

GUAIFENESIN AND DEXTROMETHORPHAN HBR 
guaifenesin and dextromethorphan hbr tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43598-114
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
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
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 (UNII: H8AV0SQX4D)  
Product Characteristics
ColorWHITE (white to off white) , GREEN (light green to green) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code 3
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43598-114-201 in 1 CARTON08/15/2023
120 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:43598-114-402 in 1 CARTON08/15/2023
220 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:43598-114-015 in 1 CARTON08/15/2023
320 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21734008/15/2023
GUAIFENESIN AND DEXTROMETHORPHAN HBR 
guaifenesin and dextromethorphan hbr tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43598-115
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
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
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 (UNII: H8AV0SQX4D)  
Product Characteristics
ColorWHITE (white to off white) , GREEN (light green to green) Scoreno score
ShapeOVALSize22mm
FlavorImprint Code 6
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43598-115-701 in 1 CARTON08/15/2023
17 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:43598-115-322 in 1 CARTON08/15/2023
27 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:43598-115-284 in 1 CARTON08/15/2023
37 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:43598-115-426 in 1 CARTON08/15/2023
47 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:43598-115-373 in 1 CARTON08/15/2023
5NDC:43598-115-7414 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21734008/15/2023
Labeler - Dr. Reddy's Laboratories Inc. (802315887)
Establishment
NameAddressID/FEIBusiness Operations
Dr. Reddy's Laboratories Limited- FTO3918608162manufacture(43598-114, 43598-115) , analysis(43598-114, 43598-115)

Revised: 8/2023
Document Id: c4b32a9e-981c-1f4f-944a-11ad9807caeb
Set id: 49d7f70d-ff79-0708-3eda-efa5bf61da6c
Version: 3
Effective Time: 20230815
 
Dr. Reddy's Laboratories Inc.