DALLERGY - chlorcyclizine hydrochloride and phenylephrine hydrochloride syrup
Laser Pharmaceuticals, LLC

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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Drug Facts

Active ingredients
(in each 5 mL teaspoonful)
Chlorcyclizine
Hydrochloride 12.5 mg
Phenylephrine
Hydrochloride 5 mg

Purpose

Antihistamine
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
reduces swelling of nasal passages

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 breathing problem such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to an enlargement of the prostate gland
heart disease
high blood pressure
thyroid disease
diabetes

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

excitability may occur, especially in children
may cause 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
new symptoms occur

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 3 doses in a 24 hour period.

Adults and children 12 years of age and over:	2 teaspoonfuls (10 mL) every 6 to 8 hours, not to exceed 6 teaspoonfuls in 24 hours
Children 6 to under 12 years of age:	1 teaspoonful (5 mL) every 6 to 8 hours, not to exceed 3 teaspoonfuls in 24 hours
Children 2 to under 6 years of age:	1/2 teaspoonful (2.5 mL) every 6 to 8 hours, not to exceed 1 1/2 teaspoonfuls in 24 hours
Children under 2 years of age:	Consult a doctor

Other information

Store at 59°-86°F (15°-30°C)

Inactive ingredients

Bitter Mask, Citric Acid, FD&C Blue #1, FD&C Red #40, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sorbitol, Sucralose.

Questions? Comments?

Call 1-864-286-8229

LASER

Manufactured for:
Laser Pharmaceuticals, LLC
Greenville, SC 29615

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 473 mL label:

NDC: 16477-820-01

Dallergy®
SYRUP

New Improved Formula

Antihistamine
Nasal Decongestant

Each 5 mL (1 teaspoonful) contains:
Chlorcylizine HCl..............................12.5 mg
Phenylephrine HCl................................5 mg

Patent Pending

Grape Flavor

LASER

16 fl oz (473 mL)

For full prescribing information, see the product foldout.

Store at 59°-86°F (15°-30°C)

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

THIS BOTTLE IS NOT TO BE DISPENSED TO THE CONSUMER.

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

The labeling for this product includes professional labeling which
is not intended for use by the general public.

WARNING: KEEP THIS AND ALL DRUGS OUT OF REACH OF
CHILDREN. IN CASE OF OVERDOSE, GET MEDICAL HELP OR
CONTACT A POISON CONTROL CENTER RIGHT AWAY.

LASER

Manufactured for:
Laser Pharmaceuticals, LLC
Greenville, SC 29615

Patent Pending

Rev. 08/2011

DALLERGY
chlorcyclizine hydrochloride, phenylephrine hydrochloride syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:16477-820
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Chlorcyclizine Hydrochloride (Chlorcyclizine)	Chlorcyclizine Hydrochloride	12.5 mg in 5 mL
Phenylephrine Hydrochloride (Phenylephrine)	Phenylephrine Hydrochloride	5 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
Citric Acid
Glycerin
Propylene Glycol
Water
Sodium Citrate
Sorbitol
Sucralose

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:16477-820-01	473 mL in 1 BOTTLE	None
2	NDC:16477-820-15	15 mL in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/18/2011

Labeler - Laser Pharmaceuticals, LLC (614417132)

Registrant - Great Southern Laboratories (056139553)

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

Revised: 10/2011 Laser Pharmaceuticals, LLC