FDA Label for Meclizine 25
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENTS (IN EACH CHEWABLE TABLET)
- PURPOSE
- INDICATIONS AND USAGE
- WARNINGS
- DO NOT TAKE UNLESS DIRECTED BY A DOCTOR IF YOU HAVE
- OTC - ASK DOCTOR/PHARMACIST
- WHEN USING THIS PRODUCT
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- INACTIVE INGREDIENTS
- QUESTIONS?
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL - 25 MG BOTTLE LABEL
Meclizine 25 Product Label
The following document was submitted to the FDA by the labeler of this product Pd-rx Pharmaceuticals, Inc.. 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.
Other
Drug Facts
Active Ingredients (In Each Chewable Tablet)
Meclizine 25 mg
Purpose
Antiemetic
Indications And Usage
prevents and treats nausea, vomiting, 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
Otc - Ask Doctor/Pharmacist
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
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding,
- ask health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222
Directions
Dosage should be taken 1 hour befor travel starts.
| Adults and children 12 years and over: | Take 1 or 2 tablets once daily, or as directed by doctor. |
Inactive Ingredients
Croscarmellose sodium, dextrose, FD& C Red #40, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium saccharine, stearic acid
Questions?
Adverse drug event call (866) 562-2756 (M-F, 8AM-4PM EST).
How Supplied
Meclizine 25mg are supplied as chewable pink round scored tablets with PH 051 embossed on them.
Supplied in bottles of 12 , 20, 30 and 100 chewable tablets.
Principal Display Panel - 25 Mg Bottle Label
Antiemetic
Each chewable tablet contains:
Meclizine HCl
25 mg
Store at 68°-77°F (20°-25°C)
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.
* Please review the disclaimer below.