Your browser does not support JavaScript! CYCLIVERT (CYCLIZINE HYDROCHLORIDE) TABLET [LASER PHARMACEUTICALS, LLC]
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CYCLIVERT (cyclizine hydrochloride) tablet
[Laser Pharmaceuticals, LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active Ingredient Section

Active Ingredient (in each tablet) Cyclizine Hydrochloride 25 mg

Purpose Section

Purpose  Antiemetic

Keep Out Of Reach Of Children Section

Keep out of reach of children.

Indications and Uses Section

Uses  For the prevention and treatment of the nausea, vomiting, or dizziness associated with motion sickness. For the treatment of vertigo of motion sickness.

Warnings Section

Warnings

Do not exceed recommended dosage.

Ask a doctor or pharmacist 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

Ask a doctor before use if you are taking sedatives, or tranquilizers.

Do not give this product to children who have a breathing problem such as chronic bronchitis or who have glaucoma, without first consulting the child's doctor.

Do not give to children under 6 years of age unless directed by a doctor.

When using this product you may get drowsy  avoid alcohol drinks  alcohol, sedatives, and tranquilizers may increase the drowsiness effect  be careful when driving a motor vehicle or operating machinery

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


Pregnancy or Breast Feeding Section

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

Dosage and Administration

Directions

Adults and children 12 years of age and over: 2 tablets every 4-6 hours, not to exceed 8 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 under 6 years of age: Consult a physician.

Inactive Ingredients Section

Inactive ingredients  magnesium Stearate, Microcrystalline Cellouse, Sodium Starch Glycolate

Other Information Section

Other Information

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

Questions? Comments? Section

Questions? Comments?

Call 1-864-286-8229

Packaging Label Section

NDC 16477-401-01 Cyclivert Tablets Antiemetic For healthcare Professionals: For the treatment of vertigo of motion sickness.

Easc tablet contains: Cyclizine HCI .........25 mg  LASER  100 tablets  Rev 9/11  Lot No:   Exp. date:

Lift Here  For full 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


Cyclivert Label


Cyclivert Label1

Cyclivert Label2

CYCLIVERT 
cyclizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:16477-401
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CYCLIZINE HYDROCHLORIDE (CHLORIDE ION) CYCLIZINE HYDROCHLORIDE25 mg  in 25 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
Colorwhite (white) Score2 pieces
ShapeROUND (Tablet) Size9mm
FlavorImprint Code LAS401
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16477-401-0125 mg in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33611/01/2011
Labeler - Laser Pharmaceuticals, LLC (614417132)
Registrant - Laser Pharmaceuticals, LLC (614417132)

Revised: 11/2011
 
Laser Pharmaceuticals, LLC

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