Dallergy DROPS

Dosage form: liquid
Ingredients: CHLORPHENIRAMINE MALEATE 1.0mg in 1.0mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 1.0mL
Labeler: Laser Pharmaceuticals, LLC
NDC Code: 16477-121

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)
Chlorpheniramine Maleate, 1.0 mg
Phenylephrine Hydrochloride, 2.5 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
  • 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 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 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 medical 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

Principal Display Panel

NDC 16477-121-30
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................................  2.5 mg
1 fl oz (30 mL)
                                    










DALLERGY DROPS 
chlorpheniramine maleate, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16477-121
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 HYDROCHLORIDE2.5 mg  in 1.0 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
PROPYLENE GLYCOL 
WATER 
SODIUM CITRATE 
SACCHARIN SODIUM 
SORBITOL 
FD&C YELLOW NO. 6 
Product Characteristics
Color    Score    
ShapeSize
FlavorPEACHImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:16477-121-301 BOTTLE (1 BOTTLE) in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/01/2014
Labeler - Laser Pharmaceuticals, LLC (614417132)

Revised: 01/2014
 
Laser Pharmaceuticals, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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