DEXTROMETHORPHAN HBR, GUAIFENESIN- dextromethorphan hbr, guaifenesin capsule, liquid filled 
OPMX LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

PENTREXCILINA
(DEXTROMETHORPHAN HBR 20MG, GUAIFENESIN 400MG SOFTGEL)

Dextromethorphan HBr 20mg

Guaifenesin 400mg

Cough suppressant

Expectorant

FD&C yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.

Do not take more than directed – See overdose warning
Do not use for more than 7 days
Do not take more than 6 doses in 24 hours

Adults and children 12 years of age and over: take 1 softgel every 4 hours with a full glass of water while symptoms persist

Children under 12 years of age: do not use

Helps loosen phlegm (mucus)
Helps thin bronchial secretions to make coughs more productive

Do not use:

Ask a doctor before use if you have:

Stop use and ask a doctor if:

Cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition

If pregnant or breast-feeding: ask a health professional before use.

Keep out of reach of children.

Keep out of reach of children

OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

store at room temperature between 20-25°C (68-77ºF)

avoid excessive heat and humidity

PENTREXCILINA

DEXTROMETHORPHAN HBR, GUAIFENESIN 
dextromethorphan hbr, guaifenesin capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-781
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
GELATIN (UNII: 2G86QN327L)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
Coloryellow (LIGHT YELLOW) Scoreno score
ShapeOVAL (Oblong) Size20mm
FlavorImprint Code 781
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69729-781-0220 in 1 BLISTER PACK; Type 0: Not a Combination Product02/18/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/18/2019
Labeler - OPMX LLC (029918743)

Revised: 4/2022
Document Id: dc7922e3-5697-0d5b-e053-2a95a90aa492
Set id: 9a16e7f3-78aa-0b01-e053-2a95a90ab19c
Version: 4
Effective Time: 20220412
 
OPMX LLC