meclizine hydrochloride tablets, usp 12.5 mg

SPL v3

SPL

SPL Set ID acdf636c-66f1-4a1f-87a8-786f51d75708

Route

oral

Published

Effective Date 2024-11-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

meclizine (12.5 mg)

Inactive Ingredients

silicon dioxide crospovidone lactose monohydrate magnesium stearate microcrystalline cellulose

Identifiers & Packaging

Pill Appearance

Imprint: AB;12 Shape: round Color: white Size: 7 mm Score: 1

Marketing Status

otc monograph drug active Since 2024-07-22

Purpose

Antiemetic

Description

Meclizine HCl, USP 12.5 mg

Medication Information

Warnings and Precautions

Do not take this product, unless directed by a doctor, if you have

glaucoma
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland

Warnings

Do not use in children under 12 years of age unless directed by a doctor.

Uses

prevents and treats nausea, vomiting or dizziness associated with motion sickness.

Purpose

Antiemetic

Directions

dosage should be taken one hour before travel starts

adults and children 12 years and over

take 2 or 4 tablets once daily or as directed by a doctor

Other Information

store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Inactive Ingredients

colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose

Description

Meclizine HCl, USP 12.5 mg

Section 42229-5

Manufactured by:

Unique Pharmaceutical Laboratories

(A Div. of J.B.Chemicals &

Pharmaceuticals Ltd.),

Mumbai 400 030, India

Mfg. Lic. No.: G/1430

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Issued: 02/2024

138528

Section 50565-1

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).

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Drug Facts

Meclizine HCl, USP 12.5 mg

Questions Or Comments?

Call 1-844-474-7464 Monday to Friday 8 AM - 5 PM ET

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

Principal Display Panel 12.5 Mg Tablets Container Label

NDC 57237-333-01

Meclizine Hydrochloride Tablets, USP

12.5 mg

100 Tablets

Structured Label Content

Warnings and Precautions (34071-1)

Do not take this product, unless directed by a doctor, if you have

glaucoma
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland

Warnings

Do not use in children under 12 years of age unless directed by a doctor.

Uses

prevents and treats nausea, vomiting or dizziness associated with motion sickness.

Purpose

Antiemetic

Directions

dosage should be taken one hour before travel starts

adults and children 12 years and over

take 2 or 4 tablets once daily or as directed by a doctor

Other Information (Other information)

store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose

Section 42229-5 (42229-5)

Manufactured by:

Unique Pharmaceutical Laboratories

(A Div. of J.B.Chemicals &

Pharmaceuticals Ltd.),

Mumbai 400 030, India

Mfg. Lic. No.: G/1430

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Issued: 02/2024

138528

Section 50565-1 (50565-1)

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).

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Drug Facts

Meclizine HCl, USP 12.5 mg

Questions Or Comments? (Questions or comments?)

Call 1-844-474-7464 Monday to Friday 8 AM - 5 PM ET

When Using This Product (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

Principal Display Panel 12.5 Mg Tablets Container Label (PRINCIPAL DISPLAY PANEL - 12.5 mg tablets container label)

NDC 57237-333-01

Meclizine Hydrochloride Tablets, USP

12.5 mg

100 Tablets

Advanced Ingredient Data

[{"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSPOVIDONE", "unii": "2S7830E561", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MECLIZINE", "unii": "3L5TQ84570", "classCode": "ACTIB", "strengthNumerator": "12.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "prevents and treats nausea, vomiting or dizziness associated with motion sickness.", "34071-1": "Do not take this product, unless directed by a doctor, if you have glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland", "42229-5": "Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B.Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India Mfg. Lic. No.: G/1430 Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Issued: 02/2024 138528", "50565-1": "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).", "53414-9": "If pregnant or breast-feeding , ask a health professional before use.", "Purpose": "Antiemetic", "Warnings": "Do not use in children under 12 years of age unless directed by a doctor.", "Directions": "dosage should be taken one hour before travel starts adults and children 12 years and over take 2 or 4 tablets once daily or as directed by a doctor", "Drug Facts": "Meclizine HCl, USP 12.5 mg", "Other information": "store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].", "Inactive ingredients": "colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose", "Questions or comments?": "Call 1-844-474-7464 Monday to Friday 8 AM - 5 PM ET", "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", "PRINCIPAL DISPLAY PANEL - 12.5 mg tablets container label": "NDC 57237-333-01 Meclizine Hydrochloride Tablets, USP 12.5 mg 100 Tablets"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:26.687510 · Updated: 2026-03-14T23:05:11.503942