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.

Active Ingredient

Active ingredient (in each tablet)

Meclizine HCL 25 mg

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

Structured Label Content

Recent Major Changes (34066-1)

Tamper evident:Do not use if safety seal is broken or missing

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.

Active Ingredient (55106-9)

Active ingredient (in each tablet)

Meclizine HCL 25 mg

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.

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

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