POLY HIST PD- thonzylamine hydrochloride and chlophedianol hydrochloride liquid

Poly Hist PD by

Drug Labeling and Warnings

Poly Hist PD by is a Otc medication manufactured, distributed, or labeled by Poly Pharmaceuticals, Inc., TG United Liquid, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

N DC 50991-222-45

Poly- Hist PD

Liquid

Antihistamine / Antitussive

4 5 mL Strawberry Flavor

INGREDIENTS AND APPEARANCE

POLY HIST PD 
thonzylamine hydrochloride and chlophedianol hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50991-222
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
THONZYLAMINE HYDROCHLORIDE (UNII: 6K9YKD48Y4) (THONZYLAMINE - UNII:R79646H5Z8)	THONZYLAMINE HYDROCHLORIDE	6.25 mg  in 1 mL
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP)	CHLOPHEDIANOL HYDROCHLORIDE	6.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50991-222-10	6 in 1 CARTON	07/01/2013	03/31/2022
1		10 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 50991-222-45	45 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2013	03/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/01/2013

Labeler - Poly Pharmaceuticals, Inc. (198449894)

Establishment
Name	Address	ID/FEI	Business Operations
TG United Liquid, Inc		830980947	manufacture(50991-222)