Meclizine Hydrochloride, USP 25 mg

Antiemetic

Chemically, Meclizine Hydrochloride, USP is 1-(p-Chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate. Meclizine Hydrochloride, USP is an oral antiemetic, which is a white to slightly yellowish crystalline powder having a slight odor and is tasteless. The molecular weight is 481.89 g/mol. It has the following structural formula:

C25H27CIN2·2HCl·H20 M.W. 481.88544 g/mol

Meclizine Hydrochloride, USP is an antihistamine that shows marked protective activity against nebulized histamine and lethal doses of intravenously injected histamine in guinea pigs. It has a marked effect in blocking the vasodepressor response to histamine, but only a slight blocking action against acetylcholine. Its activity is relatively weak in inhibiting the spasmogenic action of histamine on isolated guinea pig ileum.

For Consumers (the general public):
Naus-Ease® (Meclizine Hydrochloride), USP Tablets are used for the prevention and treatment of nausea and vomiting, or dizziness associated with motion sickness.

For Health Professionals:
Based on a review of Meclizine Hydrochloride, USP drug by the National Academy of Sciences – National Research Council and/or other information, FDA has classified the indications of Meclizine Hydrochloride, USP as follows:
1. The prevention and treatment (management) of nausea and vomiting, and dizziness associated with motion sickness.
2. For the treatment of vertigo.

Meclizine Hydrochloride, USP is contraindicated in individuals who have shown a previous hypersensitivity to it.

Clinical studies establishing safety and effectiveness in children under 12 years of age have not been done; therefore, usage is not recommended in children under 12 years of age unless directed by a doctor.

Due to its potential anticholinergic action, do not take unless directed by a doctor if you have a breathing problem such as asthma, emphysema, or chronic bronchitis, glaucoma, or difficulty in urination due to enlargement of the prostate gland.

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

When using this product:
1. Do not exceed the recommended dosage.
2. May cause drowsiness.
3. Patients should avoid alcoholic beverages while taking this drug.
4. Since drowsiness may, on occasion, occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery. Therefore patients are reminded caution when driving or operating machinery.
5. Alcohol, sedatives and tranquilizers may increase drowsiness.

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

Keep out of reach of children. In case of overdose, seek medical help or contact a Poison Control Center right away.
Call Poison Control at 1-800-222-1222

Keep out of reach of children. In case of an overdose, seek medical help or contact a Poison Control Center immediately.
Call Poison Control at 1-800-222-1222.

Anaphylactoid reaction, drowsiness, dry mouth, headache, fatigue, vomiting and, on rare occasions, blurred vision have been reported.

Adults and children 12 years of age and over: Take 1 to 2 Naus-Ease® (Meclizine Hydrochloride), USP Tablets (25 mg to 50 mg) by mouth once daily, or as directed by a physician.

The initial dose of 25 mg to 50 mg of Naus-Ease® (Meclizine Hydrochloride), USP Tablets should be taken one hour prior to travel for the prevention and treatment of motion sickness. Thereafter, the dose may be repeated every 24 hours for the duration of the journey.

Each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, D&C Yellow #10, Aluminum Lake (15-20%).

Store at controlled room temperature 20-25°C (68-77°F).

Protect from heat and humidity.

Use by expiration date on package.

Naus-Ease® (Meclizine Hydrochloride), USP Tablets are available in 25mg strengths, and is available in 8 and 16 count package sizes.

25 mg tablets; Yellow; Oval shaped; Scored; "TL121" imprinted on each tablet

Naus-Ease® (Meclizine Hydrochloride), USP; 8 Tablets: NDC 49467-124-08
Naus-Ease® (Meclizine Hydrochloride), USP; 16 Tablets: NDC 49467-124-16

Distributed by:
Sunascen Therapeutics LLC
Rockville, MD 20850 USA

Sunascen Therapeutics LLC
PO Box 2773
Wilmington DE 19805

More information is available on the web at www.nausease.com

Naus-Ease® (Meclizine Hydrochloride), USP; Tablets 25 mg Each
Antiemetic – Prevent and Treat: Nausea and Vomiting

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.