Other
Drug Facts
Pyrilamine Maleate And Dextromethorphan Hydrobromide Liquid
FDA Label NDC 69367-398
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Westminster Pharmaceuticals, Llc for the product Pyrilamine Maleate And Dextromethorphan Hydrobromide (NDC 69367-398). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| 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.
Otc - Do Not Use
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
Otc - Ask 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
Otc - Ask Doctor/Pharmacist
Ask a doctor before use if you are taking sedatives or tranquilizers.
Otc - When Using
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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)
* Please review the disclaimer below.
