DALLERGY DROPS  - chlorpheniramine maleate and phenylephrine hydrochloride liquid 
Laser Pharmaceuticals LLC

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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:

• nasal congestion
• swelling of nasal passages
• runny nose
• sneezing
• itchy, watery eyes
• itching of nose or throat
  

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

• heart disease
• high blood pressure
• thyroid disease
• diabetes mellitus
• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland
  

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

• you may get drowsy
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children
  

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• if 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 older:	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

• In mild cases or in particularly sensitive patients, less frequent or reduced doses may be adequate.
  

Other information

Store at 59° - 86°F (15° - 30° C)

Inactive ingredients

Citric Acid, FD and 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 16477-130-30

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                             
Greenvilee, SC  29615

Manufactured by:
Great Southern Laboratories
Houston, TX  77099

Rev. 02/10                                        

DALLERGY DROPS  chlorpheniramine maleate, phenylephrine hydrochloride   liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 16477-120 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate 1.0 mg  in 1.0 mL Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 2.0 mg  in 1.0 mL

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

Product Characteristics Color      Score      Shape Size Flavor PEACH Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 16477-120-30 1 BOTTLE In 1 CARTON contains a BOTTLE 1 30 mL In 1 BOTTLE This package is contained within the CARTON (16477-120-30)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/23/2005

Labeler - Laser Pharmaceuticals LLC (614417132)

Revised: 10/2010Laser Pharmaceuticals LLC