Meclizine Hcl 25 Mg

SPL v1

SPL

SPL Set ID a58d13fe-2920-3b43-e053-2a95a90a5b94

Route

ORAL

Published

Effective Date 2020-01-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Meclizine (25 mg)

Inactive Ingredients

Dextrose Fd&c Red No. 40 Magnesium Stearate Cellulose, Microcrystalline Raspberry Aspartame Sucrose Croscarmellose Sodium

Identifiers & Packaging

Pill Appearance

Imprint: AP;115 Shape: round Color: pink Size: 8 mm Score: 2

Marketing Status

OTC MONOGRAPH FINAL Active Since 2015-11-01

Description

Meclizine HCL 25 mg

Purpose

Antiemetic

Medication Information

Purpose

Antiemetic

Description

Meclizine HCL 25 mg

Uses

prevents and treats nausea, vomiting or dizziness due to motion sickness
for others uses, consult your doctor

Section 42229-5

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

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 50567-7

When using this product

you may get drowsy
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

Section 50568-5

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

Section 50569-3

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

Section 51945-4

NDC 69618-028-10

Meclizine HCL 25 mg

ANTIEMETIC

1000 TABLETS

THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN

*Compare to Active Ingredient in BONINE®

Section 53414-9

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

Warnings

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

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

When using this prodcut

you may get drowsy
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

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

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

Directions

take dose one hour before travel starts
tablets can be chewed or swallowed whole with water

adults & children 12 years and over: 1-2 tablets once daily

children unser 12 years: ask a doctor

Other Information

Phenylketonurics: each tablet contrains: phenylalanine 0.28 mg
store at room temperature 15°-30°C (59°-86°F)
This is a bulf package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

Inactive Ingredients

aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red # 40 (Al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor

Questions Or Comments?

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

Active Ingredient (in Each Tablet)

Meclizine HCL 25 mg

Package Label.principal Display Panel

Structured Label Content

Uses

prevents and treats nausea, vomiting or dizziness due to motion sickness
for others uses, consult your doctor

Section 42229-5 (42229-5)

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

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 50567-7 (50567-7)

When using this product

you may get drowsy
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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

Section 51945-4 (51945-4)

NDC 69618-028-10

Meclizine HCL 25 mg

ANTIEMETIC

1000 TABLETS

THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN

*Compare to Active Ingredient in BONINE®

Section 53414-9 (53414-9)

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

Purpose

Antiemetic

Warnings

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

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

When using this prodcut

you may get drowsy
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

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

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

Directions

take dose one hour before travel starts
tablets can be chewed or swallowed whole with water

adults & children 12 years and over: 1-2 tablets once daily

children unser 12 years: ask a doctor

Other Information (Other information)

Phenylketonurics: each tablet contrains: phenylalanine 0.28 mg
store at room temperature 15°-30°C (59°-86°F)
This is a bulf package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

Inactive Ingredients (Inactive ingredients)

aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red # 40 (Al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor

Questions Or Comments? (Questions or comments?)

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Meclizine HCL 25 mg

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data

[{"name": "DEXTROSE", "unii": "IY9XDZ35W2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "RASPBERRY", "unii": "4N14V5R27W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ASPARTAME", "unii": "Z0H242BBR1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MECLIZINE", "unii": "3L5TQ84570", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "prevents and treats nausea, vomiting or dizziness due to motion sickness for others uses, consult your doctor", "42229-5": "TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50567-7": "When using this product you may get drowsy avoid alcoholic drinks alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers", "50569-3": "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", "51945-4": "NDC 69618-028-10 Meclizine HCL 25 mg ANTIEMETIC 1000 TABLETS THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN *Compare to Active Ingredient in BONINE®", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Antiemetic", "Warnings": "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 Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this prodcut you may get drowsy avoid alcoholic drinks alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Directions": "take dose one hour before travel starts tablets can be chewed or swallowed whole with water adults & children 12 years and over: 1-2 tablets once daily children unser 12 years: ask a doctor", "Other information": "Phenylketonurics: each tablet contrains: phenylalanine 0.28 mg store at room temperature 15°-30°C (59°-86°F) This is a bulf package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.", "Inactive ingredients": "aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red # 40 (Al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor", "Questions or comments?": "call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday", "Active ingredient (in each tablet)": "Meclizine HCL 25 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:34.108275 · Updated: 2026-03-14T22:56:48.082967