MECLIZINE- meclizine hcl 12.5 mg tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Pharbest Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiemetic prevents and treats nausea, vomiting or dizziness associated with motion sickness

Authorization status:

OTC monograph final

Summary of Product characteristics

MECLIZINE- MECLIZINE HCL 12.5 MG TABLET
PHARBEST PHARMACEUTICALS, INC.
_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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DRUG FACTS
ACTIVE INGREDIENT (IN EACH CAPLET)
Meclizine HCl 12.5mg
PURPOS E
Antiemetic
US ES
prevents and treats nausea, vomiting or dizziness associated with
motion sickness
WARNINGS
DO NOT USE for children under 12 years of age unless directed by a
doctor.
DO NOT TAKE UNLESS DIRECTED BY A DOCTOR IF YOU HAVE
glaucoma
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis
DO NOT TAKE IF YOU ARE taking sedatives or tranquilizers, without
first consulting your doctor.
WHEN USING THIS PRODUCT
do not exceed recommended dosage
drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
be careful 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
dosage should be taken 1 hour before travel starts
Adults and children 12
years and over
take 2 or 4 caplets once daily or as
directed by doctor
OTHER INFORMATION
TAMPER EVIDENT: do not use if safety seal under cap is broken or
missing
store at room temperature 20°-25°C (68°-77°F)
INACTIVE INGREDIENTS
Croscarmellose sodium, dicalcium phosphate, magnesium stearate,
microcrystalline cellulose, silicon
dioxide, stearic acid
QUES TIONS ?
ADVERSE DRUG EVENT CALL [phone] (M - F, 8AM - 4PM EST).
PHARBEST
NDC 16103-0386-11
MANUFACTURED IN THE USA
MOTION SICKNESS RELIEF
MECLIZINE
MECLIZINE HCL 12.5MG
ANTI-EMETIC
• MOTION SICKNESS • NAUSEA • VOMITING
100 CAPLETS
MECLIZINE
meclizine hcl 12.5 mg tablet
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:16 10 3-38 6
ROUT