DALLERGY - chlorcyclizine hydrochloride tablet, chewable
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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Active Ingredients (in each tablet) Chlorcyclizine Hydrochloride 12.5 mg Phenylephrine Hydrochloride 5 mg
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 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.
If pregnant or breast-feeding, ask a health professional before use.
Directions
Do not exceed 3 doses in a 24 hour period.
Adults and children 12 years of age and over: 2 tablets every 6-8 hours, not to exceed 6 tablets in 24 hours.
Children 6 to under 12 years of age: 1 tablet every 6-8 hours, not to exceed 3 tablets in 24 hours.
Children 2 to under 6 years of age: 1/2 tablet every 6-8 hours, not to exceed 1-1/2 tablets in 24 hours.
Children under 2 years of age: Consult a doctor.
Inactive Ingredients
FD 7 C Blue #2/Indigo Carmine AL, Grape Flavor, Magnesium Stearate, Microcrystalline Cellulose, Mannitol, Sodium Starch Glycolate, Xylitol DC
NDC 16477-152-01 Dallergy CHEWABLE TABLETS New Improved formula Antihistamine Nasal Decongestant For Professional Use
Each tablet contains: Chlorcyclizine HCI... 12.5 mg Phenylephrine HCI... 5 mg GRAPE FLAVOR 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, chewable |
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Labeler - Laser Pharmaceuticals, LLC (614417132) |
Registrant - Laser Pharmaceuticals, LLC (614417132) |