Label: CYCLIVERT - cyclizine hydrochloride tablet
- NDC Code(s): 16477-401-01
- Packager: Laser Pharmaceuticals, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated November 14, 2011
If you are a consumer or patient please visit this version.
- Active Ingredient Section
Active Ingredient (in each tablet) Cyclizine Hydrochloride 25 mgClose
- Purpose Section
- Keep Out Of Reach Of Children Section
Keep out of reach of children.Close
- 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.Close
- Warnings Section
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.Close
- Dosage and Administration
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.Close
- Inactive Ingredients Section
Inactive ingredients magnesium Stearate, Microcrystalline Cellouse, Sodium Starch GlycolateClose
- Other Information Section
Store at 59 - 86 degrees F (15 - 30 degrees C)Close
- Questions? Comments? Section
- 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
- INGREDIENTS AND APPEARANCE
cyclizine hydrochloride tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16477-401 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CYCLIZINE HYDROCHLORIDE (UNII: W0O1NHP4WE) (CHLORIDE ION - UNII:Q32ZN48698) CYCLIZINE HYDROCHLORIDE 25 mg in 25 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color white (white) Score 2 pieces Shape ROUND (Tablet) Size 9mm Flavor Imprint Code LAS401 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16477-401-01 25 mg in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 11/01/2011 Labeler - Laser Pharmaceuticals, LLC (614417132) Registrant - Laser Pharmaceuticals, LLC (614417132)