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 Aurohealth LLC, Aurobindo Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

(in each extended-release tablet)

Dextromethorphan Hydrobromide USP 60 mg
Guaifenesin USP 1200 mg

Purpose

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.

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 (1-800-222-1222) right away.

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: 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 at 20° to 25°C (68° to 77°F)

Inactive ingredients

colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize)

Questions?

call 1-855-274-4122  You may also report side effects to this phone number.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (14 Tablet Bottle)

NDC: 58602-715-05
MAXIMUM STRENGTH
Mucus Relief DM
Guaifenesin and Dextromethorphan HBr
Extended-release Tablets
1200 mg/60 mg
EXPECTORANT AND COUGH SUPPRESSANT
12 HOUR
Controls Cough
Thins and Loosens Mucus
14 Extended-release Tablets
AUROHEALTH

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (14 Tablet Carton Label)

Compare to the active ingredients of
Maximum Strength Mucinex® DM*
NDC: 58602-715-05
Mucus Relief DM
MAXIMUM STRENGTH
Guaifenesin and Dextromethorphan HBr
Extended-release Tablets
1200 mg/60 mg
EXPECTORANT AND
COUGH SUPPRESSANT
12 HOUR
Controls Cough
Thins and Loosens Mucus
14 Extended-release Tablets
AUROHEALTH

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg Blister Carton 28 (4 x 7) Unit-dose Tablets

Comparative to the active ingredients of
Maximum Strength Mucinex® DM*
NDC: 58602-715-70
MAXIMUM STRENGTH
Mucus Relief DM
Guaifenesin and
Dextromethorphan HBr
Extended-release Tablets
1200 mg/60 mg
EXPECTORANT AND
COUGH SUPPRESSANT
12 HOUR
Controls Cough
Thins and Loosens Mucus
28 (4 x7)
Extended-release Tablets
AUROHEALTH

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: 58602-715
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE K90 (UNII: RDH86HJV5Z)
POVIDONE K25 (UNII: K0KQV10C35)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE (white to off-white)	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	X;63
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-715-05	1 in 1 CARTON	03/17/2017
1		14 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 58602-715-57	1 in 1 CARTON	03/17/2017
2		28 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 58602-715-09	1 in 1 CARTON	03/17/2017
3		30 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 58602-715-68	1 in 1 CARTON	03/17/2017
4		38 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 58602-715-60	1 in 1 CARTON	03/17/2017
5		42 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 58602-715-69	1 in 1 CARTON	03/17/2017
6		44 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 58602-715-15	1 in 1 CARTON	03/17/2017
7		60 in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 58602-715-70	4 in 1 CARTON	03/17/2017
8		7 in 1 BLISTER PACK; Type 0: Not a Combination Product
9	NDC: 58602-715-06	6 in 1 CARTON	03/17/2017
9		7 in 1 BLISTER PACK; Type 0: Not a Combination Product
10	NDC: 58602-715-65	2 in 1 CARTON	03/17/2017
10		7 in 1 BLISTER PACK; Type 0: Not a Combination Product
11	NDC: 58602-715-10	6 in 1 CARTON	03/17/2017
11		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
12	NDC: 58602-715-64	1 in 1 CARTON	03/17/2017
12		7 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	ANDA206941	03/17/2017

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurobindo Pharma Limited		650381903	ANALYSIS(58602-715) , MANUFACTURE(58602-715)