Meclizine Hydrochloride Tablets 25 Mg

SPL v2

SPL

SPL Set ID ed43bf21-f3da-245c-e053-2995a90a504c

Route

ORAL

Published

Effective Date 2022-11-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Meclizine (25 mg)

Inactive Ingredients

Silicon Dioxide Lactose Monohydrate D&c Yellow No. 10 Cellulose, Microcrystalline Magnesium Stearate

Identifiers & Packaging

Pill Appearance

Imprint: AM4 Shape: round Color: yellow Size: 9 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-11-21

Description

Active ingredient (in each 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

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

• breathing problems, such as emphysema or chronic bronchitis

• difficulty urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

• drowsiness may occur

• avoid alcoholic beverages

• alcohol, sedatives and tranquilizers may increase drowsiness

• 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

For the prevention and treatment of these symptoms associated with motion sickness • nausea • vomiting • dizziness

Dosage and Administration

Directions

to prevent motion sickness, take the first dose one hour before starting activity
not for frequent or prolonged use except on the advice of a doctor
do not exceed recommended dose

Adults and children 12 years of age and older: Take 1-2 tablets once daily, or as directed by a doctor. Do not exceed 2 tablets in 24 hours.

Description

Active ingredient (in each tablet) Meclizine HCL 25 mg

Section 42229-5

Comapre to active ingredient in DRAMAMINE ^® ALL DAY LESS DROWSY*

*This product is not manufactured or distributed by the owner of registered trademark of DRAMAMINE ^®

MADE IN USA

Manufactured by:

APNAR PHARMA LLP

East Windsor, NJ 08520

Rev.:10/2022

Section 44425-7

Other information

store at room temperature 15˚-30˚C (59˚-86˚F)
protect from humidity

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients: D&C yellow # 10 lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide.

Section 51945-4

NDC 24689-146-01

Meclizine HCL 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)

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

For the prevention and treatment of these symptoms associated with motion sickness • nausea • vomiting • dizziness

Dosage and Administration (34068-7)

Directions

to prevent motion sickness, take the first dose one hour before starting activity
not for frequent or prolonged use except on the advice of a doctor
do not exceed recommended dose

Adults and children 12 years of age and older: Take 1-2 tablets once daily, or as directed by a doctor. Do not exceed 2 tablets in 24 hours.

Warnings and Precautions (34071-1)

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

• breathing problems, such as emphysema or chronic bronchitis

• difficulty urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

• drowsiness may occur

• avoid alcoholic beverages

• alcohol, sedatives and tranquilizers may increase drowsiness

• 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)

Comapre to active ingredient in DRAMAMINE ^® ALL DAY LESS DROWSY*

*This product is not manufactured or distributed by the owner of registered trademark of DRAMAMINE ^®

MADE IN USA

Manufactured by:

APNAR PHARMA LLP

East Windsor, NJ 08520

Rev.:10/2022

Section 44425-7 (44425-7)

Other information

store at room temperature 15˚-30˚C (59˚-86˚F)
protect from humidity

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.

Section 51727-6 (51727-6)

Inactive ingredients: D&C yellow # 10 lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide.

Section 51945-4 (51945-4)

NDC 24689-146-01

Meclizine HCL 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)

Meclizine HCL 25 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34066-1": "Tamper evident:Do not use if safety seal is broken or missing", "34067-9": "Uses For the prevention and treatment of these symptoms associated with motion sickness • nausea • vomiting • dizziness", "34068-7": "Directions to prevent motion sickness, take the first dose one hour before starting activity not for frequent or prolonged use except on the advice of a doctor do not exceed recommended dose Adults and children 12 years of age and older: Take 1-2 tablets once daily, or as directed by a doctor. Do not exceed 2 tablets in 24 hours.", "34071-1": "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 • breathing problems, such as emphysema or chronic bronchitis • difficulty urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product • drowsiness may occur • avoid alcoholic beverages • alcohol, sedatives and tranquilizers may increase drowsiness • use caution when driving a motor vehicle or operating machinery If pregnant or breast-feeding ,ask a health professional before use.", "42229-5": "Comapre to active ingredient in DRAMAMINE ® ALL DAY LESS DROWSY* *This product is not manufactured or distributed by the owner of registered trademark of DRAMAMINE ® MADE IN USA Manufactured by: APNAR PHARMA LLP East Windsor, NJ 08520 Rev.:10/2022", "44425-7": "Other information store at room temperature 15˚-30˚C (59˚-86˚F) protect from humidity", "50565-1": "Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away.", "51727-6": "Inactive ingredients: D&C yellow # 10 lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide.", "51945-4": "NDC 24689-146-01 Meclizine HCL 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) Meclizine HCL 25 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:19.313137 · Updated: 2026-03-14T23:06:57.309434