Active Ingredients (In Each Chewable Tablet)
Meclizine HCl, USP 25 mg
Meclizine Hcl
FDA Label NDC 70985-010
13 label sections · Submitted to the FDA by Drug Ocean Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Drug Ocean Llc for the product Meclizine Hcl (NDC 70985-010). 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 active ingredients (in each chewable tablet), purpose, uses, warnings, otc - ask doctor/pharmacist, when using this product, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiemetic
Uses
prevents and treats nausea, vomiting or dizziness due to motion sickness.
Warnings
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
When Using This Product
- may cause drowsiness
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- use caution when driving a motor vehicle or operating machinery
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact the poison control center immediately
Directions
- Dosage should be taken one hour before travel starts
- Adults and children 12 years and older: Chew 1-2 tablets once daily, or as directed by a doctor
- Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor
Other Information
- Phenylketonurics: Contains Phenylalanine 0.0025 mg per tablet
- Store at room temperature in a dry place
- Keep lid tightly closed
Inactive Ingredients
aspartame, colloidal silicon dioxide, croscarmellose sodium, dextrose, lake of FD & C Red 40, magnesium stearate, maltodextrin, microcrystalline cellulose, raspberry flavor, sodium sulfate anhydrous, sucrose, tribasic calcium phosphate
Questions Or Comments?
Call 1-844-200-6566 Monday to Friday 9 AM to 5 PM EST
Other
TAMPER EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP, PRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING
Distributed by:
Drug Ocean LLC,
1 Bridge Plaza, North Central Road
6th Floor, Suite 675
Fort Lee, NJ 07024
Manufactured by:
Unique Pharmaceutical Laboratories
(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.)
Mumbai 400 030, India
ORG 12/23
Principal Display Panel - 25 Mg Chewable Tablet Label
NDC 70985-010-01
Meclizine Hydrochloride Chewable Tablets 25mg
(ANTIEMETIC)
Travel Sickness
100 tablets
* Please review the disclaimer below.
