MOTION SICKNESS- dimenhydrinate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M, 8-CHLOROTHEOPHYLLINE - UNII:GE2UA340FM)

Available from:

Strategic Sourcing Services LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiemetic for prevention and treatment of these symptoms associated with motion sickness: - nausea - vomiting - dizziness

Authorization status:

OTC monograph final

Summary of Product characteristics

MOTION SICKNESS- DIMENHYDRINATE 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._
----------
FOSTER AND THRIVE 44-198
_ACTIVE INGREDIENT (IN EACH TABLET)_
Dimenhydrinate 50 mg
_PURPOSE_
Antiemetic
_USES_
for prevention and treatment of these symptoms associated with motion
sickness:
nausea
vomiting
dizziness
_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 enlargement of the prostate gland
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking sedatives or tranquilizers.
WHEN USING THIS PRODUCT
alcohol, sedatives, and tranquilizers may increase drowsiness
marked drowsiness may occur
use caution when driving a motor vehicle or operating machinery
avoid alcoholic beverages
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 one-half to
one hour
before starting activity
adults
and
children
12 years
and over
1 to 2 tablets every 4-
6 hours; do not
exceed 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; do not
exceed 3 tablets in 24
hours, or as directed
by a doctor
children
2 to
under 6
years
½ tablet every 6-8
hours; do not exceed
1½ tablets in 24
hours, or as directed
by a doctor
_OTHER INFORMATION_
EACH TABLET CONTAINS: calcium 35 mg
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER
IS TORN OR BROKEN
store at 25ºC (77ºF); excursions permitted between 15º-30ºC
(59º-86ºF)
protect from moisture
see end flap for expiration date and lot number
_INACTIVE INGREDIENTS_
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