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 Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals of New York, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)(in each extended-release tablet)

Active ingredient (in each extended-release tablet)
Dextromethorphan HBr 30 mg

Guaifenesin 600 mg

Purpose

Guaifenesin - Expectorant

Dextromethorphan HBr - 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

600 mg/30 mg

• 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

• Bottle: Tamper evident: Do not use if carton is open or if printed foil under cap is broken or missing
• Blister: Do not use if carton is open or if printed seal with product name on blister is broken or missing
• store between 20° to 25°C (68° to 77°F)

Inactive ingredients

carbomer, colloidal silicon dioxide, D&C yellow #10 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and talc

Questions?

1-877-835-5472
You may also report side effects to this phone number.

Parents:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

Keep the carton. It contains important information.
See end panel for expiration date.

 †Mucinex® is a registered trademark of Reckitt Benckiser LLC.

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Rev. 02-2018-00

Principal Display Panel

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: 65162-038
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
POVIDONE (UNII: FZ989GH94E)
CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	YELLOW (light yellow)	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	AN038
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65162-038-17	2 in 1 CARTON	11/01/2018
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 65162-038-03	1 in 1 CARTON	11/01/2018
2		30 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 65162-038-06	1 in 1 CARTON	11/01/2018
3		60 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209692	11/01/2018

Labeler - Amneal Pharmaceuticals LLC (123797875)

Establishment
Name	Address	ID/FEI	Business Operations
Amneal Pharmaceuticals of New York, LLC		123797875	ANALYSIS(65162-038) , LABEL(65162-038) , MANUFACTURE(65162-038) , PACK(65162-038)