Meclizine 25mg Chew

SPL v1

SPL

SPL Set ID a2f6dab8-9424-1c25-e053-2a95a90adb08

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

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

Identifiers & Packaging

Pill Appearance

Imprint: PH051 Shape: round Color: pink Size: 8 mm Score: 2

Marketing Status

OTC MONOGRAPH FINAL Active Since 2020-01-01

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

NDC 66424-0387-01

*Compare to the active ingredient in Bonine ^®

MECLIZINE

CHEWABLE

Raspberry Flavor

Meclizine HCl 25mg

Anti-Emetic

• Motion Sickness • Nausea • Vomiting

100 TABLETS

SDA

LABORATORIES

Warnings

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

Do not take unless directed by a doctor if you have

glaucoma
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis

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

Directions

doage should be taken 1 hour before travel starts

Adults and children 12 years and over

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

Questions?

Adverse drug event call (800) 687-0176 (M - F, 8AM - 4PM EST).

Other Information

Tamper Evident: do not use if safety seal under cap is broken or missing
store at room temperature 20°-25°C (68°-77°F)

Inactive Ingredients

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

When Using This Product

do not exceed recommended dosage
drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
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.

Active Ingredient (in Each Tablet)

Meclizine HCl 25mg

Package Label.principal Display Panel

Structured Label Content

Uses

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

Section 51945-4 (51945-4)

NDC 66424-0387-01

*Compare to the active ingredient in Bonine ^®

MECLIZINE

CHEWABLE

Raspberry Flavor

Meclizine HCl 25mg

Anti-Emetic

• Motion Sickness • Nausea • Vomiting

100 TABLETS

SDA

LABORATORIES

Purpose

Antiemetic

Warnings

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

Do not take unless directed by a doctor if you have

glaucoma
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis

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

Directions

doage should be taken 1 hour before travel starts

Adults and children 12 years and over

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

Questions?

Adverse drug event call (800) 687-0176 (M - F, 8AM - 4PM EST).

Other Information (Other information)

Tamper Evident: do not use if safety seal under cap is broken or missing
store at room temperature 20°-25°C (68°-77°F)

Inactive Ingredients (Inactive ingredients)

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

When Using This Product (When using this product)

do not exceed recommended dosage
drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
be careful 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.

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

Meclizine HCl 25mg

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

Advanced Ingredient Data

[{"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": ""}, {"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 associated with motion sickness", "51945-4": "NDC 66424-0387-01 *Compare to the active ingredient in Bonine ® MECLIZINE CHEWABLE Raspberry Flavor Meclizine HCl 25mg Anti-Emetic • Motion Sickness • Nausea • Vomiting 100 TABLETS SDA LABORATORIES", "Purpose": "Antiemetic", "Warnings": "Do not use for children under 12 years of age unless directed by a doctor. Do not take unless directed by a doctor if you have glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Do not take if you are taking sedatives or tranquilizers, without first consulting your doctor.", "Directions": "doage should be taken 1 hour before travel starts Adults and children 12 years and over take 1 or 2 tablets once daily or as directed by doctor", "Questions?": "Adverse drug event call (800) 687-0176 (M - F, 8AM - 4PM EST).", "Other information": "Tamper Evident: do not use if safety seal under cap is broken or missing store at room temperature 20°-25°C (68°-77°F)", "Inactive ingredients": "Croscarmellose sodium, dextrose, FD&C Red#40, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium saccharine, stearic acid", "When using this product": "do not exceed recommended dosage drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks 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.", "Active ingredient (in each tablet)": "Meclizine HCl 25mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:11.924155 · Updated: 2026-03-14T22:56:09.845676