MOTION SICKNESS- meclizine hcl tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)

Available from:

Strategic Sourcing Services LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiemetic for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness

Authorization status:

OTC monograph final

Summary of Product characteristics

MOTION SICKNESS- MECLIZINE HCL TABLET
STRATEGIC SOURCING SERVICES 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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FOSTER AND THRIVE 44-403A
_ACTIVE INGREDIENT (IN EACH TABLET)_
Meclizine HCl 25 mg
_PURPOSE_
Antiemetic
_USES_
for the prevention and treatment of nausea, vomiting, or dizziness
associated with
motion sickness
_WARNINGS_
DO NOT USE
for children under 12 years of age unless directed by a doctor.
ASK A DOCTOR BEFORE USE IF YOU HAVE
difficulty in urination due to enlargement of the prostate gland
glaucoma
a breathing problem such as emphysema or chronic bronchitis
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking sedatives or tranquilizers.
WHEN USING THIS PRODUCT
drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives, and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery
IF PREGNANT OR BREAST-FEEDING,
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
In case of overdose, get medical help or contact a Poison Control
Center right away.
_DIRECTIONS_
DO NOT TAKE MORE THAN DIRECTED
take first dose ½ to 1 hour before starting activity
adults and children 12 years and over: 1 to 2 tablets once daily, or
as directed by a
doctor
_OTHER INFORMATION_
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER
IS TORN OR BROKEN
store at 25°C (77°F); excursions permitted between 15°-30°C
(59°-86°F)
protect from heat and humidity
see end flap for expiration date and lot number
_INACTIVE INGREDIENTS_
colloidal silicon dioxide, D&C yellow #10 aluminum lake, lactose
monohydrate,
magnesium stearate, pregelatinized starch
_QUESTIONS OR COMMENTS?_
Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST
_PRINCIPAL DISPLAY PANEL_
NDC 70677-1088-1
Foster & Thrive™
COMPARE TO
DRAMAMINE® LESS DROWSY
ACTIVE INGREDIENT*
LESS DROWSY FORMULA
MOTION SICKNESS