POLY-HIST DM- dextromethorphan hydrobromide, phenylephrine hcl and thonzylamine hcl liquid 
Poly Pharmaceuticals, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Poly-Hist DM Liquid

Drug Facts

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:

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).

PRINCIPAL DISPLAY PANEL

NDC 50991-220-16

Poly-Hist DM Liquid

Antitussive • Nasal Decongestant

Antihistamine

Bubblegum Flavor

16 fl oz (473 mL)

label

POLY-HIST DM 
dextromethorphan hydrobromide, phenylephrine hcl and thonzylamine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-220
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
THONZYLAMINE HYDROCHLORIDE (UNII: 6K9YKD48Y4) (THONZYLAMINE - UNII:R79646H5Z8) THONZYLAMINE HYDROCHLORIDE25 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50991-220-156 in 1 TRAY06/22/2013
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:50991-220-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/22/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/22/2013
Labeler - Poly Pharmaceuticals, Inc. (198449894)

Revised: 1/2024
Document Id: 0ff34ee8-6768-cfc4-e063-6294a90a4045
Set id: d1c74d4c-71bb-4934-9a4e-556366c07fca
Version: 9
Effective Time: 20240127
 
Poly Pharmaceuticals, Inc.