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Dallergy Tablets

Generic Name: chlorcyclizine hydrochloride and phenylephrine hydrochloride
Dosage Form: tablet

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.

Active Ingredient Section

Active Ingredients (in each tablet) Chlorcyclizine Hydrochloride 25 mg    Phenylephrine Hydrochloride  10 mg

Purpose Section

Antihistamine  Nasal Decongestant

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Keep Out of Reach of Children Section

Keep out of reach of children.

Indications & Uses Section

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 Section

Warnings

Do not exceed recommended dosage.

Do not use this product if you are now taking a prescription monamine 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

In case of overdose, get medical help or contact a Poison Control Center right away.

Pregnant or Breast-Feeding Section

If pregnant or breast-feeding, ask a health professional before use.

Dosage and Administration Section

Directions

Do not exceed 3 doses in a 24 hour period.

Adults and children 12 years of age and over: 1 tablet every 6-8 hours, not to exceed 3 tablets in 24 hours.

Children 6 to under 12 years of age: 1/2 tablet every 6-8 hours, not to exceed 1-1/2 tablets in 24 hours.

Children under 6 years of age: Consult a doctor.

Inactive Ingredient Section

Inactive ingredients    Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

Other Information Section

Store at 59 - 86 degrees F (15 - 30 degrees C)

Questions? Comments? Section

Questions? Comments?

Call 1-864-286-8229

Package Label Section

NDC 16477-160-01  Dallergy Tablets  New Improved formula  Antihistamine Nasal Decongestant  For Professional Use

Each tablet contains: Chlorcyclizine HCI... 25 mg   Phenylephrine HCI... 10 mg  Laser 100 Tablets  Rev 9/11  Lot No:   Exp. Date:

 For full prescribing information, see the product foldout.  Store at 59 - 86 degrees F (15 - 30 degrees C)

Tamper-evident by foil seal under cap. Do not use if foil seal is broken or missing.

This bottle is not to be dispensed to the consumer.

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

The labeling for this product includes professional labeling which is not intended for use by the general public.

WARNING: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

LASER   Manufactures for Laser Pharmaceuticals, LLC Greenville, SC 29615


DALLERGY 
chlorcyclizine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:16477-160
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORCYCLIZINE HYDROCHLORIDE (CHLORIDE ION) CHLORCYCLIZINE HYDROCHLORIDE 25 mg
PHENYLEPHRINE HYDROCHLORIDE (CHLORIDE ION) PHENYLEPHRINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
Product Characteristics
Color white (white) Score 2 pieces
Shape ROUND (Tablet) Size 9mm
Flavor Imprint Code LAS160
Contains         
Packaging
# Item Code Package Description
1 NDC:16477-160-01 100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 11/01/2011
Labeler - Laser Pharmaceuticals, LLC (614417132)
Registrant - Laser Pharmaceuticals, LLC (614417132)
Establishment
Name Address ID/FEI Operations
TG United Pharmaceuticals, Inc. 963714766 manufacture
Revised: 11/2011
 
Laser Pharmaceuticals, LLC



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