Dallergy PE Syrup

Hypersensitivity to any of the ingredients. Also contraindicated in patients with severe hypertension,
severe coronary artery disease, patients on MAO inhibitor therapy, patients with narrow angle
glaucoma, urinary retention, peptic ulcer, and during an asthmatic attack.

General:
Caution should be exercised in patients with high blood pressure, heart disease, diabetes, or thyroid
disease. The antihistamine in this product may exhibit additive effects with other CNS depressants,
including alcohol.

In all cases of suspected overdose, immediately call your regional poison center, and/or contact a
physician immediately. The stomach should be emptied promptly by lavage or by induction of
emesis with syrup of ipecac. The installation of activated charcoal into the stomach also should be
considered. The treatment of overdose is essentially symptomatic and supportive. If respiratory
depression is present, treat promptly with oxygen and/or mechanical support of ventilation. If
convulsions or marked CNS excitement occurs, only short-acting benzodiazepine-type drugs should
be used.

Adults and children 12 years of age and older:
2 teaspoonfuls (10 mL) every 4 to 6 hours.
Children 6 to under 12 years of age:
1 teaspoonful (5 mL) every 4 to 6 hours.
Children under 6 years of age:
Consult a physician.
Not to exceed 4 doses in 24 hours.

The packaging below represents the labeling currently used.

Principal Display Panel and Side Panel for 473 mL Label:

NDC: 16477-821-01

DALLERGY® PE SYRUP

Rx

Nasal Decongestant
Antihistamine
Antisecretory

Each 5 mL (1 teaspoonful) contains:
Phenylephrine Hydrochloride ........ 10 mg
Chlorpheniramine Maleate ............  2 mg
Methscopolamine Nitrate ............0.75 mg


Rx Only                   16 fl oz (473 mL)

DOSAGE AND ADMINISTRATION:
Adults and children 12 years of age and older:
2 teaspoonfuls (10 mL) every 4 to 6 hours.
Children 6 to under 12 years of age:
1 teaspoonful (5 mL) every 4 to 6 hours.
Children under 6 years of age:
Consult a physician.
Not to exceed 4 doses in 24 hours.

For full prescribing information see attached insert.

Store at controlled room temperature 20o-25oC (68o-77oF).
[See USP].

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

Dispense in a tight light-resistant container as defined in the USP/NF with a child-resistant closure.

WARNING:Keep this and all drugs out of reach of children.


Manufactured for:                               Manufactured by:
Laser Pharmaceuticals, LLC        Great Southern Laboratories
Greenville, SC 29615                          Houston, TX 77099

R06/09

Principal Display Panel and Side Panel for 30mL Label:

NDC16477-821-30

Dallergy® PE Syrup
Rx

Nasal Decongetsant / Antihistamine
Antisecretory

Each 5 mL (1 teaspoonful) contains:
Phenylephrine Hydrochloride  10 mg
Chlorpheniramine Maleate  .... 2 mg
Methscopolamine Nitrate .. 0.75 mg


Rx Only           30 mL (1 fl. oz.)

DOSAGE AND ADMINISTRATION:
Adults and children 12 years of age and older:2 teaspoonfuls (10 mL)
every 4 to 6 hours.
Children 6 to under 12 years of age:1 teaspoonful (5 mL)
every 4 to 6 hours.
Children under 6 years of age:
Consult a physician.
Not to exceed 4 doses in 24 hours.

For full prescribing information see package insert.

Store at controlled room temperature, 20o-25oC (68o-77oF). [See USP].

WARNING:Keep this and all drugs out of the reach of children.

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

Manufactured for:
Laser Pharmaceuticals, LLC
Greenville, SC 29615

Manufactured by:
Great Southern Laboratories
Houston, TX 77099   Rev. 04/09

DALLERGY  PE SYRUP phenylephrine hydrochloride, chlorpheniramine maleate, methscopolamine nitrate syrup

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:16477-821 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 10 mg  in 5 mL Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate 2 mg  in 5 mL Methscopolamine Nitrate (Methscopolamine) Methscopolamine Nitrate 0.75 mg  in 5 mL

Product Characteristics Color      Score      Shape Size Flavor GRAPE Imprint Code Contains

Packaging # Item Code Package Description 1 NDC:16477-821-01 473 mL in 1 BOTTLE 2 NDC:16477-821-30 30 mL in 1 BOTTLE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved other 04/30/2009

Labeler - Laser Pharmaceuticals LLC (614417132)

Registrant - Great Southern Laboratories (056139553)

Establishment
Name	Address	ID/FEI	Operations
Great Southern Laboratories		056139553	manufacture

Revised: 09/2009   Laser Pharmaceuticals LLC

Applies to chlorpheniramine / methscopolamine / phenylephrine: oral tablet chewable, oral tablet extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking chlorpheniramine / methscopolamine / phenylephrine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• little or no urinating;

• fast, pounding, or irregular heartbeats;

• pale skin, weakness, feeling short of breath; or

• tremors, hallucinations, severe anxiety.

Common side effects may include:

• blurred vision, headache, dizziness;

• dry mouth, nose, or throat;

• nausea; or

• feeling nervous or restless.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.