GUAIFENESIN DM- guaifenesin and dextromethorphan hydrobromide tablet 
PD-Rx Pharmaceuticals, Inc.

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Drug Facts

Active ingredients (in each tablet)

Guaifenesin 400mg

Dextromethorphan HBr 20mg

Purpose

Expectorant

Cough suppressant

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 occure with fever, rash or persistent headache

These could be signs of 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

  • take with a full glass of water
  • this product can be administered without regard for the timing of meals
  • do not exceed 6 doses in 24 hours or as directed by doctor

adults and children 12 years of age and over

take 1 tablet every 4 hours as needed

children 6 to under 12 years of age

take ½ tablet every 4 hours as needed

children under 6 years of age

consult a doctor

Other information

Inactive ingredients

magnesium stearate, maltodextrin, microcrystalline celluclose, povidone, silicon dioxide, stearic acid.

Questions?

Adverse drug event call (866) 562-2756

43063801 Label

GUAIFENESIN DM 
guaifenesin and dextromethorphan hydrobromide tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43063-801(NDC:16103-381)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeCAPSULE (CAPSULE SHAPED TABLET) Size18mm
FlavorImprint Code PH073
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43063-801-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/02/201811/30/2027
2NDC:43063-801-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/02/201811/30/2027
3NDC:43063-801-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/02/201811/30/2027
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01204/02/201811/30/2027
Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
NameAddressID/FEIBusiness Operations
PD-Rx Pharmaceuticals, Inc.156893695repack(43063-801)

Revised: 10/2023
Document Id: 06c3176d-e6f9-4231-e063-6394a90a694b
Set id: ac8c0c15-b305-47f2-8712-e4b53636f7fa
Version: 9
Effective Time: 20231002
 
PD-Rx Pharmaceuticals, Inc.