Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID ea2e6834-c11a-40f8-887c-e02419023e7b

Route

ORAL

Published

Effective Date 2019-07-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Meclizine (25 mg)

Inactive Ingredients

Croscarmellose Sodium Dextrose Fd&c Red No. 40 Magnesium Stearate Cellulose, Microcrystalline Silicon Dioxide Saccharin Sodium Stearic Acid

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2019-07-08

Description

Meclizine HCl 25mg

Purpose

Antiemetic

Medication Information

Purpose

Antiemetic

Description

Meclizine HCl 25mg

Uses

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

Section 51945-4

PHARBEST

NDC 73057-387-11

Manufactured in the USA

Chewable, Once-A-Day Protection

*Compare to the active ingredient in Bonine^®

MECLIZINE

CHEWABLE

Raspberry Flavor

Meclizine HCl 25mg

Antiemetic

• Motion Sickness • Nausea • Vomiting

1000 TABLETS

Directions

dosage should be taken one hour before travel starts

adults and children 12 years and over

take 1 or 2 tablets once daily or as directed by a doctor

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 urinating due to an enlarged prostate gland

Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

Other Information

store at 20^o-25°C (68^o-77°F)

Inactive Ingredients

croscarmellose sodium, dextrose, FD&C Red#40, raspberry flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium saccharine, stearic acid

Questions Or Comments?

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

When Using This Product

do not exceed recommended dosage
may cause drowsiness
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
use causion 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 (1-800-222-1222).

Active Ingredient (in Each Tablet)

Meclizine HCl 25mg

Structured Label Content

Uses

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

Section 51945-4 (51945-4)

PHARBEST

NDC 73057-387-11

Manufactured in the USA

Chewable, Once-A-Day Protection

*Compare to the active ingredient in Bonine^®

MECLIZINE

CHEWABLE

Raspberry Flavor

Meclizine HCl 25mg

Antiemetic

• Motion Sickness • Nausea • Vomiting

1000 TABLETS

Purpose

Antiemetic

Directions

dosage should be taken one hour before travel starts

adults and children 12 years and over

take 1 or 2 tablets once daily or as directed by a doctor

Do Not Use (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 urinating due to an enlarged prostate gland

Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

Other Information (Other information)

store at 20^o-25°C (68^o-77°F)

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dextrose, FD&C Red#40, raspberry flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium saccharine, stearic acid

Questions Or Comments? (Questions or comments?)

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

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 causion when driving a motor vehicle or operating machinery

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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).

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

Meclizine HCl 25mg

Advanced Ingredient Data

[{"name": "MECLIZINE", "unii": "3L5TQ84570", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "prevents and treats nausea, vomiting or dizziness associated with motion sickness", "51945-4": "PHARBEST NDC 73057-387-11 Manufactured in the USA Chewable, Once-A-Day Protection *Compare to the active ingredient in Bonine ® MECLIZINE CHEWABLE Raspberry Flavor Meclizine HCl 25mg Antiemetic • Motion Sickness • Nausea • Vomiting 1000 TABLETS", "Purpose": "Antiemetic", "Directions": "dosage should be taken one hour before travel starts adults and children 12 years and over take 1 or 2 tablets once daily or as directed by a doctor ", "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 urinating due to an enlarged prostate gland Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.", "Other information": "store at 20 o -25°C (68 o -77°F)", "Inactive ingredients": "croscarmellose sodium, dextrose, FD&C Red#40, raspberry flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium saccharine, stearic acid", "Questions or comments?": "(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)", "When using this product": "do not exceed recommended dosage may cause drowsiness alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks use causion 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 (1-800-222-1222).", "Active ingredient (in each tablet)": "Meclizine HCl 25mg"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:50.336059 · Updated: 2026-03-14T22:55:35.679907