DALLERGY ® TABLETS

DALLERGY  - chlorpheniramine maleate, phenylephrine hydrochloride and methscopolamine nitrate tablet 
Laser Pharmaceuticals, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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DESCRIPTION:

Each Dallergy® Tablet contains:

Chlorpheniramine Maleate ................................................4 mg

Phenylephrine Hydrochloride ..........................................10 mg

Methscopolamine Nitrate ...............................................1.25 mg

Chlorpheniramine Maleate is an antihistamine having the chemical name 2-pyridinepropanamine, γ-(4 chlorphenyl)-N,N-dimethyl, (Z)-2-butenedioate (1:1), having the following structural formula:

Figure 1: Chlorpheniramine Maleate

86b8c058-figure-01

C16H19ClN2·C4H4O4     M.W. 390.86

Phenylephrine HCl is a decongestant having the chemical name Benzenemethanol, 3-hydroxy- α-[(methylamino)methyl]-, hydrochloride, having the following structural formula:

Figure 2: Phenylephrine Hydrochloride

86b8c058-figure-02

C9H13NO2·HCl            M.W. 203.67

Methscopolamine is an anticholinergic having the chemical name 3-Oxa-9-azoniatricyclo[3.3.1.02,4] nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9,9-dimethyl-, nitrate, [7-(S)-(1α,2β,4β,5α,7β)]-, having the following structural formula:

Figure 3: Methscopolamine Nitrate

86b8c058-figure-03

C17H24NO4· NO3         M.W. 380.4

Dallergy® Tablets contain ingredients of the following therapeutic classes: antihistamine, nasal decongestant, and anticholinergic agent.

INACTIVE INGREDIENTS

calcium phosphate, magnesium stearate, methylcellulose, povidone and stearic acid

CLINICAL PHARMACOLOGY:

Chlorpheniramine maleate is an alkylamine type antihistamine.  This group of antihistamines is among the most active histamine antagonists and is generally effective in relatively low doses.  The drugs are not so prone to produce drowsiness and are among the most suitable agents for daytime use; but again, a significant proportion of patients do experience this effect.

Phenylephrine hydrochloride is a sympathomimetic which acts predominantly on alpha receptors and has little action on beta receptors.  It, therefore, functions as an oral nasal decongestant with minimal CNS stimulation.

Methscopolamine nitrate is a quaternary ammonium derivative of scopolamine, which possesses the peripheral actions of the belladonna alkaloids, but does not exhibit the central actions because of its lack of ability to cross the blood-brain barrier.  In this formulation, it is used because of its antisecretory effects on the respiratory system.

INDICATIONS AND USAGE:

For the relief of upper respiratory symptoms associated with allergies and the common cold, such as nasal congestion, sinusitis, sneezing, lacrimation, vasomotor rhinitis, post-nasal drip, and hay fever.

CONTRAINDICATIONS:

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.

WARNINGS:

Considerable caution should be exercised in patients with hypertension, diabetes mellitus, ischemic heart disease, hyperthyroidism, increased intraocular pressure, and prostatic hypertrophy.  The elderly (60 years or older) are more likely to exhibit adverse reactions.  Antihistamines may cause excitability, especially in children.  At dosages higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur.

PRECAUTIONS:

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.

Information for Patients:

Antihistamines may cause drowsiness, and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly.

Drug Interactions:

MAO inhibitors and beta adrenergic blockers increase the effects of sympathomimetics.  Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine and veratrum alkaloids.  Concomitant use of antihistamines with alcohol and other CNS depressants may have an additive effect.

Pregnancy:

Pregnancy Category C: It is not known whether Dallergy® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.  Dallergy® should be given to a pregnant woman only if clearly needed.

Nursing Mothers:

It is not known whether this drug is excreted in human milk.  Because many drugs are excreted in human milk, caution should be exercised when Dallergy® is administered to a nursing mother.

Pediatric Use:

Safety and effectiveness in pediatric patients under 6 years of age have not been established.

ADVERSE REACTIONS:

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

OVERDOSAGE AND TREATMENT OF OVERDOSE:

In all cases of suspected overdose, immediately call your regional poison control center, and/or contact a physician immediately.  The stomach should be emptied promptly by lavage.  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.

DOSAGE AND ADMINISTRATION:

Adults and children 12 years and older: one Dallergy® Tablet.  Children 6 to under 12 years of age: one-half tablet.  May be repeated in 4 to 6 hours if required for relief.  Not to exceed 4 doses in 24 hours.

HOW SUPPLIED

Bottles of 100 (NDC 0277-0160-01) white, scored tablets, debossed “LAS” to the left of the score and “160” to the right.  The opposite side of the tablet is plain.

Storage and Handling

Store at controlled room temperature 20º-25º C (68º – 77º F).  Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

Manufactured for:

Laser, LLC d/b/a Laser

Greenville, SC 29615

Rev. 01/11

PRINCIPAL DISPLAY PANEL

Figure 4: Container Label

86b8c058-figure-04

DALLERGY 
chlorpheniramine maleate, phenylephrine hydrochloride and methscopolamine nitrite tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0277-0160
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE4 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
METHSCOPOLAMINE NITRATE (METHSCOPOLAMINE) METHSCOPOLAMINE NITRATE1.25 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
MAGNESIUM STEARATE 
HYPROMELLOSE 2208 (4000 MPA.S) 
POVIDONE K30 
STEARIC ACID 
Product Characteristics
ColorWHITEScore2 pieces
ShapeCAPSULESize13mm
FlavorImprint Code LAS160
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:0277-0160-01100 TABLET ( TABLET) in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other01/24/201108/30/2011

Labeler - Laser Pharmaceuticals, LLC (614417132)
Registrant - Laser Pharmaceuticals, LLC (614417132)
Establishment
NameAddressID/FEIOperations
Sovereign Pharmaceuticals, LLC623168267MANUFACTURE

Revised: 01/2011 Laser Pharmaceuticals, LLC