[Laser Pharmaceuticals, LLC]
|Category||DEA Schedule||Marketing Status|
|HUMAN OTC DRUG LABEL||OTC monograph final|
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.
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
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
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
cyclizine hydrochloride tablet
|Labeler - Laser Pharmaceuticals, LLC (614417132)|
|Registrant - Laser Pharmaceuticals, LLC (614417132)|