Meclizine Hydrochloride Tablets

SPL v2

SPL

SPL Set ID e4d785a7-a688-3acb-e053-2a95a90a6d2e

Route

ORAL

Published

Effective Date 2022-07-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Meclizine (12.5 mg)

Inactive Ingredients

Magnesium Stearate Silicon Dioxide Lactose Monohydrate Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance

Imprint: AM7 Shape: round Color: white Size: 7 mm Size: 9 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-07-29

Description

Active Ingredient (in each tablet) 12.5mg tablet: Meclizine HCL.... 12.5 mg 25mg tablet : Meclizine HCL .....25 mg

Medication Information

Recent Major Changes

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

Warnings and Precautions

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

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

Glaucoma
A breathing problem such as emphysema or chronic bronchitis
Trouble urination due to an enlarged prostate gland

Do not take this product if you are taking

Sedatives or tranquilizers, without first consulting your doctor.

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

If pregnant or breast-feeding,

ask a health professional before use

Indications and Usage

Uses

Prevents and treats nausea, vomiting or dizziness associated with motion sickness

Dosage and Administration

Directions

Meclizine HCL 12.5mg tablet :

Dosage should be taken one hour before travel starts -adults & children 12 years and over: take 2 or 4 tablets once daily or as directed by a doctor

Meclizine HCL 25mg tablet:

Dosage should be taken one hour before travel starts -adults & children 12 years and over: take 1 or 2 tablets once daily or as directed by a doctor

Description

Active Ingredient (in each tablet) 12.5mg tablet: Meclizine HCL.... 12.5 mg 25mg tablet : Meclizine HCL .....25 mg

Section 42229-5

Rev.: 05/2022

Made in USA

Manufactured by:

APNAR PHARMA LLP

East Windsor, NJ 08520

Section 44425-7

Other Information:

store at 20°to 25°C (68°to 77°F), excursions permitted between 15°to 30°C (59°to 86°F) [see USP controlled room temperature]

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 51727-6

Inactive Ingredients

Magnesium stearate, microcrystalline cellulose,silicon dioxide, lactose monohydrate

Section 51945-4

NDC : 24689-138-01

Meclizine Hydrochloride Tablets 12.5 mg

Antiemetic

100 Tablets

NDC : 24689-139-01

Meclizine Hydrochloride Tablets 25 mg

Antiemetic

100 Tablets

Section 53413-1

Questions or Comments?

Call 1-855-642-2594

Section 55105-1

Purpose

Antiemetic

Section 55106-9

Active Ingredient (in each tablet)

12.5mg tablet: Meclizine HCL.... 12.5 mg

25mg tablet : Meclizine HCL .....25 mg

Structured Label Content

Recent Major Changes (34066-1)

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

Indications and Usage (34067-9)

Uses

Prevents and treats nausea, vomiting or dizziness associated with motion sickness

Dosage and Administration (34068-7)

Directions

Meclizine HCL 12.5mg tablet :

Dosage should be taken one hour before travel starts -adults & children 12 years and over: take 2 or 4 tablets once daily or as directed by a doctor

Meclizine HCL 25mg tablet:

Dosage should be taken one hour before travel starts -adults & children 12 years and over: take 1 or 2 tablets once daily or as directed by a doctor

Warnings and Precautions (34071-1)

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

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

Glaucoma
A breathing problem such as emphysema or chronic bronchitis
Trouble urination due to an enlarged prostate gland

Do not take this product if you are taking

Sedatives or tranquilizers, without first consulting your doctor.

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

If pregnant or breast-feeding,

ask a health professional before use

Section 42229-5 (42229-5)

Rev.: 05/2022

Made in USA

Manufactured by:

APNAR PHARMA LLP

East Windsor, NJ 08520

Section 44425-7 (44425-7)

Other Information:

store at 20°to 25°C (68°to 77°F), excursions permitted between 15°to 30°C (59°to 86°F) [see USP controlled room temperature]

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 51727-6 (51727-6)

Inactive Ingredients

Magnesium stearate, microcrystalline cellulose,silicon dioxide, lactose monohydrate

Section 51945-4 (51945-4)

NDC : 24689-138-01

Meclizine Hydrochloride Tablets 12.5 mg

Antiemetic

100 Tablets

NDC : 24689-139-01

Meclizine Hydrochloride Tablets 25 mg

Antiemetic

100 Tablets

Section 53413-1 (53413-1)

Questions or Comments?

Call 1-855-642-2594

Section 55105-1 (55105-1)

Purpose

Antiemetic

Section 55106-9 (55106-9)

Active Ingredient (in each tablet)

12.5mg tablet: Meclizine HCL.... 12.5 mg

25mg tablet : Meclizine HCL .....25 mg

Advanced Ingredient Data

[{"name": "MECLIZINE", "unii": "3L5TQ84570", "classCode": "ACTIB", "strengthNumerator": "12.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MECLIZINE", "unii": "3L5TQ84570", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "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": ""}]

Raw Label Data

All Sections (JSON)

{"34066-1": "TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING", "34067-9": "Uses Prevents and treats nausea, vomiting or dizziness associated with motion sickness", "34068-7": "Directions Meclizine HCL 12.5mg tablet : Dosage should be taken one hour before travel starts -adults & children 12 years and over: take 2 or 4 tablets once daily or as directed by a doctor Meclizine HCL 25mg tablet: Dosage should be taken one hour before travel starts -adults & children 12 years and over: take 1 or 2 tablets once daily or as directed by a doctor", "34071-1": "Do not use in children under 12 years of age unless directed by a doctor Do not take this product, unless directed by a doctor, if you have Glaucoma A breathing problem such as emphysema or chronic bronchitis Trouble urination due to an enlarged prostate gland Do not take this product if you are taking Sedatives or tranquilizers, without first consulting your doctor. 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 If pregnant or breast-feeding, ask a health professional before use", "42229-5": "Rev.: 05/2022 Made in USA Manufactured by: APNAR PHARMA LLP East Windsor, NJ 08520", "44425-7": "Other Information: store at 20°to 25°C (68°to 77°F), excursions permitted between 15°to 30°C (59°to 86°F) [see USP controlled room temperature]", "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)", "51727-6": "Inactive Ingredients Magnesium stearate, microcrystalline cellulose,silicon dioxide, lactose monohydrate", "51945-4": "NDC : 24689-138-01 Meclizine Hydrochloride Tablets 12.5 mg Antiemetic 100 Tablets NDC : 24689-139-01 Meclizine Hydrochloride Tablets 25 mg Antiemetic 100 Tablets", "53413-1": "Questions or Comments? Call 1-855-642-2594", "55105-1": "Purpose Antiemetic", "55106-9": "Active Ingredient (in each tablet) 12.5mg tablet: Meclizine HCL.... 12.5 mg 25mg tablet : Meclizine HCL .....25 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:19.301123 · Updated: 2026-03-14T23:06:57.309434