Your browser does not support JavaScript! POLY HIST PD (THONZYLAMINE HYDROCHLORIDE AND CHLOPHEDIANOL HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.]
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RxNorm Names

POLY HIST PD (thonzylamine hydrochloride and chlophedianol hydrochloride) liquid
[Poly Pharmaceuticals, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Drug Facts

Active ingredient

6.25 mg Thonzylamine HCl per 1 mL

Purpose

Antihistamine

Active ingredients

6.25 mg Chlophedianol HCl per 1 mL

Purpose

Antitussive

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
  • calms the cough control center and relieves coughing
  • runny nose
  • sneezing
  • itching of the nose and throat
  • itchy, watery eyes

Warnings

Ask a doctor before use if

a child has

  • 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

Ask a doctor or pharmacist before use if

a child is taking sedatives or tranquilizers. 

When using this product

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • sedatives and tranquilizers may increase the drowsiness effect

Stop use and ask a doctor if

  • cough 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
  • new symptoms occur

Keep out of reach of children.

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

Directions

Do not exceed recommended dosage.

  • Use only with enclosed dropper
  • Do not use enclosed dropper for any other drug product

Children 2 to under 6 years of age: 2 mL every 6 hours not to exceed 8 mL in 24 hours, or as directed by a doctor

Children under 2 years of age: consult a doctor

Other information

Store at 20°-25°C (68°-77°F); excursions
permitted to 15°-30°C (59°-86°F).
[See USP Controlled Room Temperature].

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Inactive ingredients

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

 

Questions?

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).

Manufactured for Poly Pharmaceuticals,
Quitman, MS 39355

Rev. 06/13

PRINCIPAL DISPLAY PANEL

NDC 50991-222-45
Poly-
Hist PD
Liquid

Antihistamine /
Antitussive
4
5 mL Strawberry Flavor

PRINCIPAL DISPLAY PANEL
NDC 50991-222-45
Poly-Hist PD
Liquid
Antihistamine / Antitussive
45 mL Strawberry Flavor

PRINCIPAL DISPLAY PANEL
NDC 50991-222-45
Poly-Hist PD
Liquid
Antihistamine / Antitussive
45 mL Strawberry Flavor

POLY HIST PD 
thonzylamine hydrochloride and chlophedianol hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50991-222
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
THONZYLAMINE HYDROCHLORIDE (THONZYLAMINE) THONZYLAMINE HYDROCHLORIDE6.25 mg  in 1 mL
CHLOPHEDIANOL HYDROCHLORIDE (CHLOPHEDIANOL) CHLOPHEDIANOL HYDROCHLORIDE6.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
AMMONIUM GLYCYRRHIZATE 
METHYLPARABEN 
POTASSIUM CITRATE 
POTASSIUM SORBATE 
PROPYLPARABEN 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
SUCRALOSE 
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50991-222-4545 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/01/2013
Labeler - Poly Pharmaceuticals, Inc. (198449894)

Revised: 6/2013
 
Poly Pharmaceuticals, Inc.

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