GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE- guaifenesin and dextromethorphan hydrobromide tablet, extended release 
OHM LABORATORIES INC

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Guaifenesin 600 mg & Dextromethorphan HBr 30 mg Extended-Release Tablets

Drug Facts

Active ingredients (in each extended-release tablet)Purposes
Dextromethorphan HBr 30 mgCough suppressant
Guaifenesin 600 mgExpectorant

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

Other information

Inactive ingredients

carbomer homopolymer type B; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Questions?

(1-800-406-7984)

You may also report side effects to this phone number.

Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512

PRINCIPAL DISPLAY PANEL - 40 Tablet Blister Pack Carton

Compare To
the active ingredients of
Mucinex® DM

NDC 51660-054-41

ohm®

Guaifenesin 600 mg
& Dextromethorphan HBr 30 mg
Extended-Release Tablets

Expectorant & Cough Suppressant

12 Hour

40 Extended-Release Tablets

PRINCIPAL DISPLAY PANEL - 40 Tablet Blister Pack Carton
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 
guaifenesin and dextromethorphan hydrobromide tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-054
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin600 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize22mm
FlavorImprint Code xeunciM;1200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51660-054-411 in 1 CARTON10/01/2019
140 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02162010/01/2019
Labeler - OHM LABORATORIES INC (184769029)
Establishment
NameAddressID/FEIBusiness Operations
RECKITT BENCKISER HEALTHCARE INTERNATIONAL LTD230780363MANUFACTURE(51660-054)

Revised: 10/2019
Document Id: 7e0db0cc-7fda-45f6-959c-a9c2f6d2066b
Set id: eaea42f3-c119-4f41-8be2-33e3ebceccf6
Version: 1
Effective Time: 20191002
 
OHM LABORATORIES INC