DALLERGY- dexbrompheniramine maleate and phenylephrine hcl tablet 
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 Tablets

Active ingredients

(in each tablet)
Dexbrompheniramine Maleate 1 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.

Directions

Adults and children
12 years of age
and over: 		2 tablet
every 4 hours,
not to exceed
12 tablets
in 24 hours.
Children 6 to under
12 years of age: 		1 tablet
every 4 hours,
not to exceed
6  tablets in
24 hours.
Children under
6 years of age: 		Consult a
doctor.

Do not exceed 6 doses in a 24 hour period.

Other Information

Store at 59° - 86°F (15° - 30°C)

Inactive ingredients

calcium phosphate dihydrate, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, silicified microcrystalline cellulose

Questions? Comments?

Call 1-864-286-8229

Principal Display Panel

NDC 16477-161-01 
Dallergy TABLETS  
Improved Formulation
Antihistamine • Nasal Decongestant 
Each tablet contains:
Dexbrompheniramine Maleate 1 mg
Phenylephrine HCI 5 mg
100 Tablets

NDC 16477-161-01 Dallergy TABLETS Improved Formulation Antihistamine • Nasal Decongestant Each tablet contains: Dexbrompheniramine Maleate 1 mg Phenylephrine HCI 5 mg 100 Tablets


DALLERGY 
dexbrompheniramine maleate and phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16477-161
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE1 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
Colorwhite (white) Score2 pieces
ShapeROUND (Tablet) Size8mm
FlavorImprint Code LAS;161
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16477-161-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/01/201412/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/01/201412/31/2017
Labeler - Laser Pharmaceuticals, LLC (614417132)

Revised: 12/2017
Document Id: 617271ba-eb1d-f9d8-e053-2a91aa0a28d5
Set id: f567b8ff-d476-4e14-838e-8f62467790cf
Version: 5
Effective Time: 20171228
 
Laser Pharmaceuticals, LLC