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  5. Label Information: Pyrilamine Maleate And Dextromethorphan Hydrobromide

FDA Label for Pyrilamine Maleate And Dextromethorphan Hydrobromide

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - WHEN USING
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL - 473 ML BOTTLE LABEL

Pyrilamine Maleate And Dextromethorphan Hydrobromide Product Label

The following document was submitted to the FDA by the labeler of this product Westminster Pharmaceuticals, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Otc - Purpose



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:

  • 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 - pyrilamine 01

Principal Display Panel - 473 mL Bottle Label - pyrilamine 01


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