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Dallergy

Laser Pharmaceuticals, LLC
Woodfield Pharmaceutical, LLC

Dallergy SYRUP Improved Formulation


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Active ingredients

(in each 5 mL teaspoonful)

Dexbrompheniramine Maleate 1 mg

Phenylephrine Hydrochloride 5 mg

Purpose

Purpose

Antihistamine

Nasal Decongestant

Uses

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 ar e 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

Dallergy

Other information

Store at 59°-86°F (15°-30°C)

Inactive ingredients

Citric Acid, FD&C Blue #1, FD&C Red #40, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

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:  16477-822-01

Dallergy®
SYRUP


Improved

Formulation

Antihistamine
Nasal Decongestant


Each 5 mL (1 teaspoonful) contains:
Dexbrompheniramine Maleate.............1  mg
Phenylephrine HCl................................5 mg


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. 11/13

Dallergy

Dallergy

Dallergy

Dexbrompheniramine Maleate, Phenylephrine Hydrochloride SYRUP

Product Information

Product Type Human otc drug label Item Code (Source) NDC:16477-822
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Dexbrompheniramine Maleate DEXBROMPHENIRAMINE 1 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
propylene glycol
water
SODIUM CITRATE
saccharin sodium
sorbitol

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:16477-822-01 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-06-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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