DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid 
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, and Phenylephrine HCl

Drug Facts

Active ingredients (in each 15 mL (TBSP)Purpose
Dextromethorphan HBr 18 mgCough Suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 10 mgNasal Decongestant

Uses

Warnings

Do Not Use 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

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

When using this product do not use more than directed

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not improve within 7 days or are accompanied by a fever, rash or persistent headache. A persistant 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 Poison Control Center right away.

Directions

Adults and children 12 years of age and over:15 mL (1 TBSP) every 4 hours, not to exceed 90 mL (6 TBSP) in a 24 hour period
Children 6 to under 12 years of age:7.5 mL (1/2 TBSP) every 4 hours, not to exceed 45 mL (3 TBSP) in a 24 hour period
Children under 6 years of age:Consult a doctor.

Other information

Other ingredients

citric acid anhydrous, glycerin, masking agent, propylene glycol, purified water, rasberry flavor, sodium benzoate, sodium citrate dihydrate, sodium saccharin, sorbitol.

Questions or Comments?

PRINCIPAL DISPLAY PANEL - 240 mL Bottle Label

NDC 69367-184-08

Cough
Cold/Congestion

Dextromethorphan HBr
Guaifenesin
Phenylephrine HCl

Each 15 mL (TBSP) contains:
Dextromethorphan HBr 18 mg
Guaifenesin 200 mg
Phenylephrine HCl 10 mg

Cough Suppressant • Expectorant • Nasal Decongestant

Rasberrry Flavor

Alcohol Free/ Sugar Free
Gluten Free/ Dye Free

8 fl. oz. (240 mL)

Westminster
Pharmaceuticals

Principal Display Panel - 240 mL Bottle Label
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE 
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69367-184
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE18 mg  in 15 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SORBITOL (UNII: 506T60A25R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
Color    Score    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69367-184-08240 mL in 1 BOTTLE; Type 0: Not a Combination Product03/15/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/15/2018
Labeler - Westminster Pharmaceuticals, LLC (079516651)

Revised: 11/2021
Document Id: 8be6ab2b-2dfa-4b7f-a37e-81388d12b0e3
Set id: a58bfb14-28f9-4425-a5a5-aaff4847c979
Version: 5
Effective Time: 20211129
 
Westminster Pharmaceuticals, LLC