Label: PYRILAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE liquid
- NDC Code(s): 69367-398-16
- Packager: Westminster Pharmaceuticals, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated August 26, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
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
-
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
- Inactive ingredients
- Questions or Comments?
-
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
NDC: 69367-398-16
Pyrilamine Maleate
and
Dextromethorphan HBr
LiquidAntitussive • Antihistamine
Sugar Free • Alcohol Free
• Dye Free • Gluten FreeEach teaspoonful (5 mL) for oral
administration contains:Dextromethorphan HBr
7.5 mgPyrilamine Maleate
7.5 mgCandy 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 liquidProduct 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)