drug facts

drug facts

SPL v1

SPL

SPL Set ID 2e2c8189-c026-48f8-bbc6-371498ccf444

Route

oral

Published

Effective Date 2026-01-14

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 raspberry

Identifiers & Packaging

Pill Appearance

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

Marketing Status

otc monograph drug active Since 2026-01-14

Purpose

Antiemetic

Description

Meclizine HCl 25mg

Medication Information

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 aretaking sedatives or tranquilizers, without first consulting your doctor.

Active Ingredient

Meclizine HCl 25mg

Uses

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

Purpose

Antiemetic

Directions

doage should be taken 1 hour before travel starts
adults and children 12 years and over: take 1 to 2 tablets once daily or as directed by doctor

Other Information

store at room temperature 20°-25°C (68°-77°F)
DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive Ingredients

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

Description

Meclizine HCl 25mg

Section 51945-4

Questions Or Comments?

call toll free 1-844-912-4012

When Using This Product

do not exceed recommended dosage
drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
use caution 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 (800-222-1222) right away.

Structured Label Content

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 aretaking sedatives or tranquilizers, without first consulting your doctor.

Active Ingredient (Active ingredient (in each tablet))

Meclizine HCl 25mg

Uses

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

Purpose

Antiemetic

Directions

doage should be taken 1 hour before travel starts
adults and children 12 years and over: take 1 to 2 tablets once daily or as directed by doctor

Other Information (Other information)

store at room temperature 20°-25°C (68°-77°F)
DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive Ingredients (Inactive ingredients)

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

Section 51945-4 (51945-4)

Questions Or Comments? (Questions or comments?)

call toll free 1-844-912-4012

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
use caution 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 (800-222-1222) right away.

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": "RASPBERRY", "unii": "4N14V5R27W", "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", "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 to 2 tablets once daily or as directed by doctor", "Other information": "store at room temperature 20°-25°C (68°-77°F) DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED", "Inactive ingredients": "Croscarmellose sodium, dextrose, FD&C Red#40, raspberry flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium saccharine, stearic acid", "Questions or comments?": "call toll free 1-844-912-4012", "When using this product": "do not exceed recommended dosage drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks use caution 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 (800-222-1222) right away.", "Active ingredient (in each tablet)": "Meclizine HCl 25mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:13.306224 · Updated: 2026-03-14T23:12:23.079612