POLY HIST NC- codeine phosphate, pseudoephedrine hydrochloride and triprolidine hydrochloride liquid
Poly Pharmaceuticals, Inc.

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.

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Poly Hist NC

POLY HIST NC - codeine phosphate, pseudoephedrine HCl and triprolidine HCl liquid

Drug Facts

Active ingredients

(in each 5 mL teaspoonful)
Codeine Phosphate 10 mg
Pseudoephedrine Hydrochloride 15 mg
Triprolidine Hydrochloride 1.25 mg

Purpose

Antitussive (cough suppressant)
Nasal decongestant
Antihistamine Uses

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

a cough due to minor throat and bronchial irritation
nasal congestion
reduces swelling of nasal passages
runny nose
sneezing
itching of the nose or throat, itchy, watery eyes

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
a chronic pulmonary disease or shortness of breath, or children who are taking other drugs
heart disease
high blood pressure
thyroid disease
diabetes
difficulty in urination due to the enlargement of the prostate gland
a breathing problem such as emphysema or chronic bronchitis
glaucoma

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

may cause or aggravate constipation
excitability may occur, especially in children
may cause marked drowsiness
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase the drowsiness effect
Be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or are accompanied by fever

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             1 to 2 teaspoonfuls (5-10 mL) every
12 years of age and over       4-6 hours, not to exceed 8 teaspoonfuls
                                                (40 mL) in a 24 hour period.

Children 6 to under             1/2 to 1 teaspoonful (2.5 to 5 mL) every
12 years of age:                   4-6 hours, not to exceed 4 teaspoonfuls
                                                (20 mL) in a 24 hour period.

Children under 6 years of age: Not recommended for use.

Other information

Store at 59° - 86°F (15° - 30°C)

Inactive ingredients

Citric Acid, Cotton Candy Flavor, Glycerin, Propylene Glycol, Purified Water, Sodium Saccharin, Sorbitol.

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 50991-528-16
POLY HIST NC
LIQUID
Antitussive • Nasal Decongestant • Antihistamine

Each 5mL(1 teaspoonful) for oral administration contains:
Codeine Phosphate* .................. 10 mg
*(WARNING: May be habit forming)
Pseudoephedrine HCl ................ 15 mg
Triprolidine HCl .....................1.25 mg
Cotton Candy Flavor
Alcohol Free / Sugar Free
Dye Free
CV
473 mL

NDC 50991-528-16
POLY HIST NC
LIQUID
Antitussive • Nasal Decongestant • Antihistamine

Each 5mL(1 teaspoonful) for oral administration contains:
Codeine Phosphate* .................. 10 mg
*(

POLY HIST NC
codeine phosphate, pseudoephedrine hydrochloride and triprolidine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50991-528
Route of Administration	ORAL	DEA Schedule	CV

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)	CODEINE PHOSPHATE	10 mg in 1 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	15 mg in 1 mL
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	1.25 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	COTTON CANDY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50991-528-15	12 in 1 TRAY	01/10/2010	02/01/2018
1		15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:50991-528-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2010	02/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	01/01/2010	02/01/2018

Labeler - Poly Pharmaceuticals, Inc. (198449894)

Revised: 2/2018

Document Id: 64a80189-ab0d-e3f9-e053-2991aa0a84e3

Set id: 96a2f945-bace-431e-8fd6-d73a6dc1baea

Version: 2

Effective Time: 20180207

Poly Pharmaceuticals, Inc.