GLEN PE- phenylephrine hydrochloride and pyrilamine maleate syrup

Glen PE by

Drug Labeling and Warnings

Glen PE by is a Otc medication manufactured, distributed, or labeled by Glendale Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each teaspoonful)	Purpose
Pyrilamine Maleate 16 mg	Antihistamine
Phenylephrine Hydrochloride 5 mg	Nasal Decongestant

Uses

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

• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes
• nasal congestion
• temporarily restores freer breathing through the nose
• reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do not use this product

• to sedate a child or make a child sleepy
• 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
• diabetes
• glaucoma
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

• taking any other nasal decongestant or stimulant
• taking sedatives or tranquilizers

When using this product

• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.

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 6 dosage in a 24-hour period.

• Adults and children 12 years of age and over: 2 teaspoonfuls every 4 hours
• Children under 12 years of age: Consult a physician

Other information

Store at 59°-86°F (15°-30°C) [see USP for Controlled Room Temperature]

Inactive ingredients

Citric acid, cotton candy flavor, FD&C Red #40, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol.

Questions? Comments?

To report a serious adverse event or obtain product information, Call 1-630-530-7000.

SPL UNCLASSIFIED SECTION

Distributed by:
Glendale Inc
Villa Park, IL 60181

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC: 70147-0224-16

Glen PE

Antihistamine
Nasal Decongestant

Each teaspoonful for oral
administration contains:
Pyrilamine Maleate 16 mg
Phenylephrine HCl 5 mg

SUGAR FREE /
ALCOHOL FREE

Cotton Candy Flavored Liquid

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

Distributed by:
Glendale Inc
Villa Park, IL 60181

16 fl oz. (473 mL)

INGREDIENTS AND APPEARANCE

GLEN PE 
phenylephrine hydrochloride and pyrilamine maleate syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70147-224
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	15 mg  in 5 mL
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	16 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
FD&C red no. 40 (UNII: WZB9127XOA)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70147-224-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/05/2015

Labeler - Glendale Inc (079987961)