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

Drug Details [pdf]

Active Ingredients

(in each extended-release tablet)

Dextromethorphan Hydrobromide USP 30 mg
Guaifenesin USP 600 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 or 2 tablets every 12 hours; not more than 4 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 1-877-932-7948 You may also report side effects to this phone number. 

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/30 mg Blister Carton 20 Tablets

compare to
Mucinex DM®
Active Ingredients*
NDC: 41163-030-67
EQUAILINE®
mucus-DM
guaifenesin 600 mg/
dextromethorphan HBr 30 mg
extended-release tablets
(expectorant/
cough suppressant)
12 hour
controls Cough
thins and loosens mucus

20 Tablets

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: 41163-030
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
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	16mm
Flavor		Imprint Code	X;62
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41163-030-67	2 in 1 CARTON	03/17/2017
1		10 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 - SUPERVALU INC (006961411)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurobindo Pharma Limited		650381903	ANALYSIS(41163-030) , MANUFACTURE(41163-030)