GUAIFENESIN AND DEXTROMETHORPHAN HBR- guaifenesin and dextromethorphan hbr tablet, extended release 
Amneal Pharmaceuticals LLC

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Guaifenesin and Dextromethorpham HBr Extended-Release Tablets, 1200 mg/60 mg

EXPECTORANT & COUGH SUPPRESSANT

Drug Facts

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

Active ingredient (in each extended-release tablet)
Dextromethorphan HBr 60 mg

Guaifenesin 1200 mg

Purpose

Guaifenesin - Expectorant

Dextromethorphan HBr - 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

1200 mg/60 mg

Other information

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. 04-2018-01

Principal Display Panel

1200mg Blister Pack
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GUAIFENESIN AND DEXTROMETHORPHAN HBR 
guaifenesin and dextromethorphan hbr tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65162-039
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 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)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
Coloryellow (light yellow) Scoreno score
ShapeOVALSize22mm
FlavorImprint Code AN039
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65162-039-172 in 1 CARTON11/01/2018
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:65162-039-031 in 1 CARTON11/01/2018
230 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:65162-039-061 in 1 CARTON11/01/2018
360 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20969211/01/2018
Labeler - Amneal Pharmaceuticals LLC (123797875)
Establishment
NameAddressID/FEIBusiness Operations
Amneal Pharmaceuticals of New York, LLC123797875analysis(65162-039) , label(65162-039) , manufacture(65162-039) , pack(65162-039)

Revised: 10/2024
Document Id: bdfe8cad-61bb-48eb-a5c4-ec21abde055a
Set id: cfdbcdb0-531a-4d95-ac5d-64d6d034b252
Version: 15
Effective Time: 20241025
 
Amneal Pharmaceuticals LLC