Other
Drug Facts
Meclizine Tablet, Chewable
FDA Label NDC 43063-804
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pd-rx Pharmaceuticals, Inc. for the product Meclizine (NDC 43063-804). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
43063804 Label (43063804)
* Please review the disclaimer below.
