Label: TRAVEL-EASE - meclizine hydrochloride tablet
- NDC Code(s): 57896-778-01, 57896-778-02
- Packager: Geri-Care Pharmaceutical Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Active ingredient (in each tablet)
Meclizine HCI 25mgClose
For the prevention and treatment of these symptoms associated with motion sickness • nausea • vomiting • dizzinessClose
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
• difficulty urinating due to an enlarged prostate gland
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.
• 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 humidityClose
- Inactive ingredients
croscarmellose sodium, D and C yellow no. 10 lake, lactose, magnesium stearate, microcrystalline cellulose, silica, sodium starch glycolate, starch, stearic acidClose
- package label
Meclizine Hydrochloride/ Antiemetic
for prevention and treament of motion sickness
less drowsy formula
all day relief
Compare to active ingredient in DRAMAMINE II
25 mg each
- INGREDIENTS AND APPEARANCE
meclizine hcl tablet
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57896-778 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE STARCH, CORN MAGNESIUM STEARATE D&C YELLOW NO. 10 SODIUM STARCH GLYCOLATE TYPE A POTATO CROSCARMELLOSE SODIUM STEARIC ACID Product Characteristics Color yellow Score no score Shape ROUND Size 9mm Flavor Imprint Code TCL086 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57896-778-02 20 in 1 BOTTLE 2 NDC:57896-778-01 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 01/01/2004 Labeler - Geri-Care Pharmaceutical Corp (611196254) Registrant - Geri-Care Pharmaceutical Corp (611196254)