GUAIFENESIN AND DEXTROMETHORPHAN HBR- guaifenesin and dextromethorphan hbr tablet, extended release 
OHM LABORATORIES INC

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Guaifenesin and Dextromethorphan HBr

Drug Facts

Active ingredients (in each extended-release tablet)Purposes
Dextromethorphan HBr 60 mgCough suppressant
Guaifenesin 1200 mgExpectorant

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 extended-release 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 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours
  • children under 12 years of age: do not use

Other information

  • Store between 20-25°C (68-77°F)

Inactive ingredients

carbomer homopolymer, colloidal silicon dioxide, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), stearic acid

Questions?

(1-800-406-7984)

You may also report side effects to this phone number.

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901

PRINCIPAL DISPLAY PANEL - 14 Tablet Blister Pack Carton

†Compare To
the active ingredients of
Maximum Strength
Mucinex® DM

NDC 51660-110-54

ohm®

Maximum Strength

Guaifenesin 1200 mg
& Dextromethorphan HBr 60 mg
Extended-Release Tablets

Expectorant & Cough Suppressant

12 Hour

  • Controls Cough
  • Thins and Loosens Mucus
  • Immediate and Extended Release

14 Extended-Release Tablets

PRINCIPAL DISPLAY PANEL - 14 Tablet Blister Pack Carton
GUAIFENESIN AND DEXTROMETHORPHAN HBR 
guaifenesin and dextromethorphan hbr tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-110
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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POVIDONE K30 (UNII: U725QWY32X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITE (off-white) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code 053
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51660-110-541 in 1 CARTON07/01/2021
114 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21478107/01/2021
Labeler - OHM LABORATORIES INC (184769029)
Registrant - SUN PHARMACEUTICAL INDUSTRIES, INC. (146974886)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries Limited650456002MANUFACTURE(51660-110)

Revised: 8/2021
Document Id: 101833c2-c740-4a7d-b697-21fa6bb9d5b8
Set id: 07b9854d-1ec6-4c8a-983e-96ed1e2de1c2
Version: 2
Effective Time: 20210824
 
OHM LABORATORIES INC