DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet 
Westminster Pharmaceuticals, 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.

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Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl

DRUG FACTS

Active ingredients (in each tablet)Purpose
Dextromethorphan HBr 17.5mgCough Suppressant
Guaifenesin 385mgExpectorant
Phenylephrine HCl 10mgNasal Decongestant

Uses

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • nasal congestion
  • reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do not use this product

  • 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

  • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlargement of the prostate gland

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.
  • A persistent cough may be a sign of a serious condition.
  • new symptoms occur

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.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over:1 tablet every 4 hours, not to exceed 6 tablets in 24 hours.
Children 6 to under 12 years of age:1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours.
Children under 6 years of age:Consult a doctor.

Other Information

Store at 15°-30°C (59°-86°F)

Supplied in a tight, light-resistant container with a child-resistant cap. Dextromethorphan HBr; Guaifenisan; Phenylephrine HCl tablets are orange, oblong, capsule shaped, scored tablets, debossed "WP" bisect "198" on one side and plain on the other.

Inactive ingredients

FD&C Yellow #6, D&C Yellow #10, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

Questions? Comments?

Call 1-844-221-7294

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

NDC 69367-198-90

Dextromethorphan HBr
Guaifenesin
Phenylephrine HCl

Cough Suppressant • Expectorant
Nasal Decongestant

Each tablet contains:

Dextromethorphan HBr
17.5 mg

Guaifenesin
385 mg

Phenylephrine HCl
10 mg

90 Tablets

Westminster
Pharmaceuticals

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE 
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69367-198
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE17.5 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN385 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorORANGEScore2 pieces
ShapeOVALSize16mm
FlavorImprint Code WP;198
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69367-198-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/25/201804/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/25/201804/01/2024
Labeler - Westminster Pharmaceuticals, LLC (079516651)

Revised: 12/2022
Document Id: 5eda0c05-7c22-4189-8594-7e5d39ac4c17
Set id: 5630060f-553a-442e-bc1e-8fa124993023
Version: 4
Effective Time: 20221212
 
Westminster Pharmaceuticals, LLC