MOTION SICKNESS- dimenhydrinate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M)

Available from:

TOP CARE (Topco Associates 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- DIMENHYDRINATE TABLET
TOP CARE (TOPCO ASSOCIATES 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._
----------
DRUG FACTS
ACTIVE INGREDIENT (IN EACH TABLET)
Dimenhydrinate 50 mg
PURPOS E
Antiemetic
US ES
for the prevention and treatment of nausea, vomiting, or dizziness
associated with motion sickness.
WARNINGS
DO NOT USE
for children under 2 years of age, unless directed by a doctor.
ASK A DOCTOR BEFORE USE IF YOU HAVE
a breathing problem such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to an enlargement of the prostate gland
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking sedatives or tranquilizers.
WHEN USING THIS PRODUCT
marked drowsiness may occur
avoid alcoholic drinks
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
to prevent motion sickness, the first dose should be taken ½ to 1
hour before starting activity
adults and children 12
1 to 2 tablets every 4-6 hours; not to exceed
adults and children 12
years and over
8 tablets in 24 hours or as directed by a
doctor
children 6 to under 12
years
½ to 1 tablet every 6-8 hours; not to exceed 3
tablets in 24 hours or as directed by a doctor
children 2 to under 6
years
¼ to ½ tablet every 6-8 hours; not to exceed
1-½ tablets in 24 hours or as directed by a
doctor
OTHER INFORMATION
each tablet contains: CALCIUM 30 MG
store at room temperature 20º-25ºC (68º-77ºF)
INACTIVE INGREDIENTS
croscarmellose sodium, dicalcium phosphate, magnesium stearate,
microcrystalline cellulose
QUESTIONS OR COMMENTS?
Call toll free 1-888-423-0139
PRINCIPAL DISPLAY PANEL
ORIGINAL FORMULA
MOTION SICKNE