DALLERGY- chlorcyclizine hydrochloride, 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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Dallergy SYRUP

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

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. 08/12

Dallergy SYRUP Packaging


Dallergy SYRUP Packaging

DALLERGY 
chlorcyclizine hydrochloride, phenylephrine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16477-820
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORCYCLIZINE HYDROCHLORIDE (UNII: NPB7A7874U) (CHLORCYCLIZINE - UNII:M26C4IP44P) CHLORCYCLIZINE HYDROCHLORIDE12.5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16477-820-01473 mL in 1 BOTTLE; Type 0: Not a Combination Product10/18/201107/03/2017
2NDC:16477-820-1515 mL in 1 BOTTLE; Type 0: Not a Combination Product10/18/201107/03/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/18/201107/03/2017
Labeler - Laser Pharmaceuticals, LLC (614417132)
Registrant - Pernix Manufacturing, LLC (078641814)

Revised: 11/2017
 
Laser Pharmaceuticals, LLC