Poly-hist Dm
FDA Label NDC 50991-220

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Poly Pharmaceuticals, Inc. for the product Poly-hist Dm (NDC 50991-220). 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 active ingredients, purpose, uses, warnings, do not use this product, ask a doctor before use if you have, ask a doctor or pharmacist before use if, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

(in each 5 mL teaspoonful)
Dextromethorphan HBr 10 mg
Phenylephrine HCI 5 mg
Thonzylamine HCl 25 mg

Purpose

Antitussive

Nasal Decongestant
Antihistamine

Uses

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

  • cough due to minor throat and bronchial irritation
  • runny nose
  • sneezing
  • itching of the nose and throat
  • itchy, watery eyes
  • nasal congestion
  • reduces swelling of nasal passages

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

Ask A Doctor Before Use If You Have

  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes

Ask A Doctor Or Pharmacist Before Use If

you are taking sedatives or tranquilizers.

When Using This Product

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

Stop Use And Ask A Doctor If:

  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
  • nervousness, dizziness, or sleeplessness occur
  • new symptoms occur

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over:2 teaspoonfuls (10 mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours, or as directed by a doctor.
Children 6 to under 12 years of age:1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor.
Children 2 to under 6 years of age:Consult a doctor.

Other Information

Store at 59 ○- 86 ○F (15 ○ - 30 ○C)

Inactive Ingredients

Bubblegum Flavor, Citric Acid, Magnasweet, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol, Sucralose.

 

Questions? Comments?

Serious side effects associated with use of this product may be reported to this number. Call 1-800-882-1041 Mon. - Fri. (8 a.m. to 5 p.m. CST).

* Please review the disclaimer below.