505f6036-d216-4455-e054-00144ff88e88

SPL v4

SPL

SPL Set ID 505f6036-d216-4455-e054-00144ff88e88

Route

oral

Published

Effective Date 2015-10-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

meclizine (25 mg)

Inactive Ingredients

croscarmellose sodium fd&c red no. 40 cellulose, microcrystalline tricalcium phosphate aspartame sucrose dextrose magnesium stearate maltodextrin silicon dioxide sodium sulfate

Identifiers & Packaging

Pill Appearance

Imprint: 21G Shape: round Color: pink Size: 8 mm Score: 2

Marketing Status

otc monograph final active Since 2015-10-15

Purpose

Antiemetic

Description

Meclizine HCl, USP 25 mg

Medication Information

Warnings

WARNINGS

Uses

prevents and treats nausea, vomiting or dizziness due to motion sickness

Purpose

Antiemetic

Directions

Dosage should be taken one hour before travel starts.

Adults and children 12 years of age and older: Chew 1-2 tablets once daily or as directed by a doctor

Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor.

Other Information

store at room temperature

Inactive Ingredients

aspartame, croscarmellose sodium, dextrose, FD&C Red #40 Lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.

Description

Meclizine HCl, USP 25 mg

Principal Display Panel

Ask Doctor

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

Do Not Use

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

When Using

When using this product

may cause drowsiness

alcohol, sedatives, and tranquilizers may increase drowsiness

avoid alcoholic drinks

use caution when driving a motor vehicle or operating machinery

Ask Doctor/pharmacist

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

Questions Or Comments?

If you have any questions or comments or to report an adverse event, please contact (800) 795-9775.

Other Safety Information

Phenylketonurics: Contains phenylalanine 0.28 mg per tablet

Do not use if imprinted safety seal under cap is broken or missing

Pregnancy 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 the poison control center immediately.

Active Ingredient (in Each Chewable Tablet)

Meclizine HCl, USP 25 mg

Structured Label Content

Warnings (WARNINGS)

WARNINGS

Uses (USES)

prevents and treats nausea, vomiting or dizziness due to motion sickness

Purpose (PURPOSE)

Antiemetic

Directions (DIRECTIONS)

Other Information (OTHER INFORMATION)

store at room temperature

Inactive Ingredients (INACTIVE INGREDIENTS)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Ask Doctor (ASK DOCTOR)

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

Do Not Use (DO NOT USE)

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

When Using (WHEN USING)

When using this product

may cause drowsiness

alcohol, sedatives, and tranquilizers may increase drowsiness

avoid alcoholic drinks

use caution when driving a motor vehicle or operating machinery

Ask Doctor/pharmacist (ASK DOCTOR/PHARMACIST)

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

Questions Or Comments? (QUESTIONS OR COMMENTS?)

If you have any questions or comments or to report an adverse event, please contact (800) 795-9775.

Other Safety Information (OTHER SAFETY INFORMATION)

Phenylketonurics: Contains phenylalanine 0.28 mg per tablet

Do not use if imprinted safety seal under cap is broken or missing

Pregnancy Or Breast Feeding (PREGNANCY 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)

Keep out of reach of children.

In case of overdose, get medical help or contact the poison control center immediately.

Active Ingredient (in Each Chewable Tablet) (ACTIVE INGREDIENT (IN EACH CHEWABLE TABLET))

Meclizine HCl, USP 25 mg

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": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRICALCIUM PHOSPHATE", "unii": "K4C08XP666", "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": "DEXTROSE", "unii": "IY9XDZ35W2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM SULFATE", "unii": "0YPR65R21J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USES": "prevents and treats nausea, vomiting or dizziness due to motion sickness", "PURPOSE": "Antiemetic", "WARNINGS": "WARNINGS", "ASK DOCTOR": "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", "DIRECTIONS": "Dosage should be taken one hour before travel starts. Adults and children 12 years of age and older: Chew 1-2 tablets once daily or as directed by a doctor Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor.", "DO NOT USE": "Do not use in children under 12 years of age unless directed by a doctor.", "WHEN USING": "When using this product may cause drowsiness alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks use caution when driving a motor vehicle or operating machinery", "OTHER INFORMATION": "store at room temperature", "INACTIVE INGREDIENTS": "aspartame, croscarmellose sodium, dextrose, FD&C Red #40 Lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.", "ASK DOCTOR/PHARMACIST": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.", "QUESTIONS OR COMMENTS?": "If you have any questions or comments or to report an adverse event, please contact (800) 795-9775.", "OTHER SAFETY INFORMATION": "Phenylketonurics: Contains phenylalanine 0.28 mg per tablet Do not use if imprinted safety seal under cap is broken or missing", "PREGNANCY 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 the poison control center immediately.", "ACTIVE INGREDIENT (IN EACH CHEWABLE TABLET)": "Meclizine HCl, USP 25 mg"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:57:01.811392 · Updated: 2026-03-14T22:55:53.187482