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 30 mgCough suppressant
Guaifenesin 600 mgExpectorant

Uses

Warnings

Do not use

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, 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 - 40 Tablet Blister Pack Carton

Compare To
the active ingredients of
Mucinex® DM

NDC 51660-301-41

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 HBR 
guaifenesin and dextromethorphan hbr tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-301
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
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 054
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51660-301-211 in 1 CARTON07/01/2021
120 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:51660-301-412 in 1 CARTON07/01/2021
220 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(51660-301)

Revised: 8/2021
Document Id: eb963e6d-d883-41dd-96ed-5284d105a8f4
Set id: f2eb5494-2672-444f-afa3-d1ef8ed1eaa1
Version: 2
Effective Time: 20210830
 
OHM LABORATORIES INC