DALLERGY DROPS - chlorpheniramine maleate and phenylephrine hydrochloride liquid 
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.

----------

Dallergy DROPS

Drug Facts

Active ingredients
(in each 1 mL dropperful)

Chlorpehniramine Maleate, 1.0 mg
Phenylephrine Hydrochloride, 2.0 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
  • trouble urinating due to an enlarged 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 a fever

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

· Do not exceed recommended dosage.
· Dosages may be repeated every 4-6 hours if required for relief.
· Use enclosed dropper only.  Do not use any other dosage device.
Adults and Children
12 years of age and
over:
4 dropperfuls (4 mL) every 4-6 hours.
Not to exceed more than 6 doses in
24 hours.
Children 6 to under
12 years of age:

2 dropperfuls (2 mL) every 4-6 hours.
Not to exceed more than 6 doses in
24 hours.
Children under
6 years of age:
Consult a doctor


Other information

Store at 59° - 86°F (15° - 30° C)

Inactive ingredients

Citric Acid, FD&C Yellow #6, Glycerin, Peach Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

Questions? Comments?

Call your doctor for medial advice about side effects.  Serious side effects associated with this product may be reported to this number.
1-864-286-8229 (Mon-Fri) 8am-5pm EST

Product Packaging

The packaging below represents the labeling currently used.

Principal Display Panel and Side Panel for 30 mL Label:

NDC 16477-120-30

Dallergy DROPS

Sugar Free / Alcohol Free

Antihistamine
Nasal Decongestant

Peach Flavored


Each dropperful (1.0 mL), for oral administration, contains:
Chlorpheniramine Maleate......................  1.0 mg
Phenylephrine HCl................................  2.0 mg


1 fl oz (30 mL)

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

Supplied in a tight, light-resistant container with a child-resistant closure.

Manufactured for:                                                   
Laser Pharmaceuticals, LLC                             
Greenville, SC  29615

Manufactured by:
Great Southern Laboratories
Houston, TX  77099

Rev. 05/12                                       

Dallergy DROPS Packaging



Dallergy DROPS Packaging


Dallergy DROPS Packaging




DALLERGY DROPS 
chlorpheniramine maleate, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:16477-120
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate1.0 mg  in 1.0 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride2.0 mg  in 1.0 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid Monohydrate 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorPEACHImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16477-120-301 in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/23/2005
Labeler - Laser Pharmaceuticals LLC (614417132)
Registrant - Pernix Manufacturing, LLC (078641814)
Establishment
NameAddressID/FEIBusiness Operations
Pernix Manufacturing, LLC dba Great Southern Laboratories078641814manufacture(16477-120)

Revised: 12/2012
 
Laser Pharmaceuticals LLC