Label: POLYTUSSIN DM- dexchlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl syrup
- NDC Code(s): 50991-492-15, 50991-492-16
- Packager: Poly Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated November 27, 2017
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- ACTIVE INGREDIENT
- ASK DOCTOR/PHARMACIST
INDICATIONS & USAGE
- temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- Temporarily relieves these symptoms due to hay fever (allergic rhinitis):
- Runny nose
- itching of the nose or throat
- itchy, watery eyes
- Temporarily restores freer breathing through the nose
Do not use 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
- heart disease
- high blood pressure
- thyroid disease
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlarged prostrate gland
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
- cough accompanied by excessive phlegm (mucus)
When using this product < do not exceed recommended dosage < marked drowsiness may occur < alcohol, sedatives, and tranquilizers may increase the drowsiness effect < avoid alcoholic beverages < use caution when driving a motor vehicle or operating machinery < excitability may occur especially in children
Stop use and ask a doctor if < cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. < symptoms do not improve within 7 days or are accompanied by fever < nervousness, dizziness, or sleeplessness occur
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
OTHER SAFETY INFORMATION
Store at room temperature 15°C-30°C (59°F-86°F)
Questions? Call 1-800-882-1041. You may also report serious side effects to this phone number.
Take under guidance of Health Professionals.
Children 2-6 years of age: 2.5 mL every 4 hours, not to
exceed 15 mL in a 24 hour period.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
dexchlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl syrup
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50991-492 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE 1 mg in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 5 mL Inactive Ingredients Ingredient Name Strength SODIUM BENZOATE (UNII: OJ245FE5EU) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor COTTON CANDY (clear, colorless) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50991-492-16 480 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/22/2017 2 NDC:50991-492-15 15 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/22/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/22/2017 Labeler - Poly Pharmaceuticals, Inc. (198449894) Establishment Name Address ID/FEI Business Operations Monarch PCM LLC 080000294 manufacture(50991-492)