GUAIFENESIN AND DEXTROMETHORPHAN HBR tablet, extended release

Guaifenesin and Dextromethorphan HBR by

Drug Labeling and Warnings

Guaifenesin and Dextromethorphan HBR by is a Otc medication manufactured, distributed, or labeled by Dr. Reddy's Laboratories Inc., Dr. Reddy's Laboratories Limited- FTO3. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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.

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 tablet
• take with a full glass of water
• this product can be administered without regard for timing of meals
• children under 12 years of age: do not use

For 600 mg/30 mg:

• adults and children 12 years and older: 1 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours.

For 1200 mg/60 mg:

• adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours.

Other information

• store at 20°C to 25°C (68°F to 77°F)

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.

SPL UNCLASSIFIED SECTION

Distributed by:

Dr. Reddy’s Laboratories, Inc.

Princeton, NJ 08540

Made in India

PRINCIPAL DISPLAY PANEL

Guaifenesin 600 mg and Dextromethorphan 30 mg Extended-Release Tablets

Carton:

PRINCIPAL DISPLAY PANEL

Guaifenesin 1200 mg and Dextromethorphan 60 mg Extended-Release Tablets

Carton:

INGREDIENTS AND APPEARANCE

GUAIFENESIN AND DEXTROMETHORPHAN HBR 
guaifenesin and dextromethorphan hbr tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43598-231
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	600 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (white to off white) , GREEN (light green to green)	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	3
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43598-231-01	5 in 1 CARTON	11/23/2023
1		20 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA217340	08/15/2023

GUAIFENESIN AND DEXTROMETHORPHAN HBR 
guaifenesin and dextromethorphan hbr tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43598-232
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	1200 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	60 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (white to off white) , GREEN (light green to green)	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	6
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43598-232-37	3 in 1 CARTON	12/01/2023
1		14 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA217340	08/15/2023

Labeler - Dr. Reddy's Laboratories Inc. (802315887)

Establishment
Name	Address	ID/FEI	Business Operations
Dr. Reddy's Laboratories Limited- FTO3		918608162	manufacture(43598-231, 43598-232) , analysis(43598-231, 43598-232)