POLY-HIST DM- dexchlorpheniramine maleate and dextromethorphan hbr liquid

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each 5mL teaspoonful)

Dexchlorpheniramine Maleate: 1mg

Dextromethorphan HBr: 10mg

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

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 of 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.

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.

QUESTIONS

Questions? Comments?

Call 1-800-882-1041

Manufactured for:

Poly Pharmaceuticals

Huntsville, AL 35763

PURPOSE

Antihistamine

Cough Suppressant

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

POLY-HIST DM 
dexchlorpheniramine maleate and dextromethorphan hbr liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50991-271
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N)	DEXCHLORPHENIRAMINE MALEATE	1 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
CITRIC ACID (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
METHYLPARABEN (UNII: A2I8C7HI9T)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50991-271-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/23/2026
2	NDC: 50991-271-15	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/23/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/23/2026

Labeler - POLY PHARMACEUTICALS, INC. (198449894)

Establishment
Name	Address	ID/FEI	Business Operations
BEO Pharma Inc		105153330	manufacture(50991-271)