MOTION SICKNESS RELIEF- 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:

Chain Drug Consortium, LLC

INN (International Name):

MECLIZINE HYDROCHLORIDE

Composition:

MECLIZINE HYDROCHLORIDE 25 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiemetic For the prevention and treatment of these symptoms associated with motion sickness • nausea • vomiting • dizziness

Authorization status:

OTC monograph final

Summary of Product characteristics

MOTION SICKNESS RELIEF- MECLIZINE HCL TABLET
CHAIN DRUG CONSORTIUM, 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._
----------
PV 778
ACTIVE INGREDIENT (IN EACH TABLET)
Meclizine HCI 25mg
PURPOSE
Antiemetic
USES
For the prevention and treatment of these symptoms associated with
motion sickness •
nausea • vomiting • dizziness
WARNINGS
DO NOT USE in children under 12 years of age unless directed by a
doctor.
ASK A DOCTOR BEFORE USE IF YOU HAVE
• breathing problems, such as emphysema or chronic bronchitis
• glaucoma
• difficulty urinating due to an enlarged prostate gland
A SK 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
I F 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
to prevent motion sickness, take the first dose one hour before
starting activity
not for frequent or prolonged use except on the advice of a doctor
do not exceed recommended dose
Adults and children 12
years if age and older
Take 1-2 tablets once daily, or as directed by a doctor.
Do not exceed 2 tablets in 24 hours.
OTHER INFORMATION
• TAMPER EVIDENT:Do not use if imprinted seal under cap is broken or
missing.
• store at room temperature 15˚-30˚C (59˚-86˚F)
• protect from humidity
INACTIVE INGREDIENTS
croscarmellose sodium, D and C yellow no. 10 lake, lactose, magnesium
stearate,
microcrystalline cellulose, silica, sodium starch glycolate, starch,
stearic acid
PACKAGE LABEL
MOTION SICKNESS RELIEF
meclizine hcl tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOU