PYRILAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE liquid

Pyrilamine Maleate and Dextromethorphan Hydrobromide by

Drug Labeling and Warnings

Pyrilamine Maleate and Dextromethorphan Hydrobromide by is a Otc medication manufactured, distributed, or labeled by Westminster Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each 5 mL teaspoonful)	Purpose
Dextromethorphan HBr 7.5 mg	Antitussive
Pyrilamine Maleate 7.5 mg	Antihistamine

Uses

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

• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes
• cough due to minor throat and bronchial irritation associated with a cold
• alleviates cough to help you sleep
• nonnarcotic cough suppressant for the relief of cough

Warnings

Do not exceed recommended dosage.

• a persistent cough may be a sign of a serious condition. If cough persist for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.

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

INGREDIENTS AND APPEARANCE

PYRILAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE 
pyrilamine maleate and dextromethorphan hydrobromide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69367-398
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	7.5 mg  in 5 mL
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	7.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	APPLE (Candy Apple)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69367-398-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M012	07/15/2024

Labeler - Westminster Pharmaceuticals, LLC (079516651)