PYRILAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE- pyrilamine maleate and dextromethorphan hydrobromide liquid 
Westminster Pharmaceuticals, LLC

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Pyrilamine Maleate and Dextromethorphan Hydrobromide

Drug Facts

Active ingredient (in each 5 mL teaspoonful)Purpose
Dextromethorphan HBr 7.5 mgAntitussive
Pyrilamine Maleate 7.5 mgAntihistamine

Uses

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

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
  • for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor before use if you are taking sedatives or tranquilizers.

When using this product

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • sedatives and tranquilizers may increase drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery

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

Keep out of reach of children.

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over:4 teaspoonfuls every 6-8 hours, not to exceed 16 teaspoonfuls in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age:2 teaspoonfuls every 6-8 hours, not to exceed 8 teaspoonfuls in 24 hours, or as directed by a doctor
Children under 6 years of age:Consult a doctor

Other information

Store at room temperature 15°C-30°C (59°F-86°F)

Inactive ingredients

Anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose.

Questions or Comments?

Call 1-844-221-7294 M-F (9 a.m. to 5 p.m. EST)

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC: 69367-398-16

Pyrilamine Maleate
and
Dextromethorphan HBr
Liquid

Antitussive • Antihistamine

Sugar Free • Alcohol Free
• Dye Free • Gluten Free

Each teaspoonful (5 mL) for oral
administration contains:

Dextromethorphan HBr
7.5 mg

Pyrilamine Maleate
7.5 mg

Candy Apple Flavor

Tamper evident by foil seal under cap.
Do not use if foil is broken or missing.

Supplied in a tight container with a
child-resistant cap.

16oz. (473mL)

Westminster
Pharmaceuticals

Principal Display Panel - 473 mL Bottle Label
PYRILAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE 
pyrilamine maleate and dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69367-398
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE7.5 mg  in 5 mL
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE7.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorAPPLE (Candy Apple) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69367-398-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH DRUGM01207/15/2024
Labeler - Westminster Pharmaceuticals, LLC (079516651)

Revised: 8/2024
Document Id: c0f27c81-43c1-4e63-b3a4-ccbd15f35ab4
Set id: dd068449-9d24-41e6-8a6e-f69c9fe263f2
Version: 2
Effective Time: 20240826
 
Westminster Pharmaceuticals, LLC