FDA Label for Meclizine Hydrochloride
View Indications, Usage & Precautions
- DRUG FACTS
- OTC - PURPOSE
- USES
- DO NOT USE IN
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF
- WHEN USING THIS PRODUCT
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS OR COMMENTS?
- OTHER
- HOW SUPPLIED
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Meclizine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Bryant Ranch Prepack. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active ingredient (in each chewable tablet)
Meclizine HCl 25 mg
Otc - Purpose
Purpose
Antiemetic
Uses
prevents and treats nausea, vomiting or dizziness due to motion sickness
Do Not Use In
children under 12 years of age unless directed by a doctor
Ask A Doctor Before Use If You Have
glaucoma
a breathing problem such as emphysema or chronic bronchitis
trouble 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
Do not exceed recommended dosage
may cause drowsiness
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
use caution when driving a motor vehicle or operating machinery
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
Dosage should be taken one hour before travel starts
| adults and children 12
years of age and over | chew 1 to 2 tablets once daily, or as directed by a doctor |
| children under
12 years of age | do not give this product to children under 12 years of age
unless directed by a doctor |
Other Information
Each tablet contains 0.09 mg of Magnesium and 0.82 mg of Sodium
store at room temperature in a dry place
keep lid tightly closed
Inactive Ingredient
Croscarmellose Sodium, Crospovidone, FD&C Red #40 Lake, French Vanilla Flavor, Lactose, Magnesium Stearate, Raspberry Flavor, Silica, Sodium Saccharin, Stearic Acid
Questions Or Comments?
1-800-645-2158
Other
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Prestige Brands, Inc owner of the registered trademark Bonine®.
Distributed by:
RUGBY® LABORATORIES
17177 N Laurel Park Dr., Suite 233
Livonia, MI 48152
www.rugbylaboratories.com
How Supplied
NDC: 71335-2177-1: 30 Tablets in a BOTTLE
NDC: 71335-2177-2: 20 Tablets in a BOTTLE
NDC: 71335-2177-3: 25 Tablets in a BOTTLE
NDC: 71335-2177-4: 40 Tablets in a BOTTLE
NDC: 71335-2177-5: 60 Tablets in a BOTTLE
NDC: 71335-2177-6: 90 Tablets in a BOTTLE
NDC: 71335-2177-7: 8 Tablets in a BOTTLE
NDC: 71335-2177-8: 14 Tablets in a BOTTLE
NDC: 71335-2177-9: 10 Tablets in a BOTTLE
NDC: 71335-2177-0: 120 Tablets in a BOTTLE
Package Label.Principal Display Panel
Meclizine 25MG Chewable
* Please review the disclaimer below.