Otc - Active Ingredient
Active Ingredients (in each 5mL teaspoonful)
Dexchlorpheniramine Maleate: 1mg
Dextromethorphan HBr: 10mg
Poly-hist Dm Liquid
FDA Label NDC 50991-271
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 50991-271). 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 otc - active ingredient, indications & usage, warnings, dosage & administration, inactive ingredient, otc - questions, otc - purpose, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
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 nose or throat
- itchy, watery eyes
Warnings
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
- 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
- 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
- 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
Ask a doctor before use if you have
Ask a doctor of pharmacist before use if you are taking sedatives or tranquilizers.
When using this product
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Dosage & Administration
Directions
Adults and children 12 years of age and over: 2 teaspoonfuls (10mL) 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 (5mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor.
Children under 6 years of age: Consult a doctor.
Inactive Ingredient
Inactive Ingredients
Bubblegum Flavor, Citric Acid, Magnasweet, Methy Paraben, Potassium Citrate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol, Sucralose.
Otc - Questions
Questions? Comments?
Call 1-800-882-1041
Manufactured for:
Poly Pharmaceuticals
Huntsville, AL 35763
Otc - Purpose
Antihistamine
Cough Suppressant
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Package Label.Principal Display Panel
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