Dallergy 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.

Adverse reactions include drowsiness, lassitude, nausea, giddiness, dryness of mouth, blurred vision, cardiac
palpitations, flushing, increased irritability or excitement (especially in children).

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). Children 6 to under 12
years of age: 1 teaspoonful (5 mL). May be repeated in 4 to 6 hours if required for relief. Not to exceed
4 doses in 24 hours. Children under 6: at discretion of physician.

The packaging below represents the labeling currently used:

Principal Display and Side Panel for 473 mL Label:

NDC: 16477-819-01

Dallergy
SYRUP

New Improved Formula

Rx

Nasal Decongestant
Antihistamine
Antisecretory

Each 5 mL (1 teaspoonful) contains:
Chlorpheniramine Maleate.......... 2 mg
Phenylephrine Hydrochloride...... 8 mg
Methscopolamine Nitrate........ 0.75 mg

LASER

Rx Only

16 fl oz (473 mL)

USUAL DOSAGE:
Adults and children 12 years and older: 2 teaspoonfuls (10 mL)
Children 6 to under 12 years of age: 1 teaspoonful (5 mL)
May be repeated in 4 to 6 hours if required for relief. Not to exceed 4 doses in 24 hours.
Children under 6: at discretion of physician.

For full prescribing information see attached insert.

Store at controlled room temperature 15o-30oC (59o-86oF).

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 USF/NF with a child-resistant closure.

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

LASER

Manufactured for:
Laser Pharmaceuticals, LLC
Greenville, SC 29615

Manufactured by:
Great Southern Laboratories
Houston, TX 77099




Rev. 09/09

DALLERGY  chlorpheniramine maleate, phenylephrine hydrochloride, methscopolamine nitrate syrup

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:16477-819 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate 2 mg  in 5 mL Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 8 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:16477-819-01 473 mL in 1 BOTTLE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/06/2006

Labeler - Laser Pharmaceuticals LLC (614417132)

Registrant - Great Southern Laboratories (056139553)

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

Revised: 04/2010   Laser Pharmaceuticals LLC