Motion Sickness

SPL v3

SPL

SPL Set ID 98e3fe5a-73c6-4dcc-b397-cc6013beee43

Route

ORAL

Published

Effective Date 2017-10-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Meclizine (25 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

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

Marketing Status

OTC MONOGRAPH FINAL Active Since 2015-05-01

Description

Meclizine Hydrochloride 25 mg

Purpose

Antiemetic

Medication Information

Purpose

Antiemetic

Description

Meclizine Hydrochloride 25 mg

Uses

For the prevention and treatment of nausea, vomiting or dizziness associated with motion sickness. For other uses consult your doctor

Warnings

Ask a doctor before use if you have

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

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

When using this product

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

Directions

take dose one hour before travel starts

tablets can be chewed or swallowed whole with water

adults & children 12 years and over:

take 1-2 tablets once daily

children under 12 years:

ask a doctor

Active Ingredient

Meclizine Hydrochloride 25 mg

Other Information

Phenylketonurics:

each tablet contains:

phenylalanine 0.28 mg

store at room temparature 15 - 30 °C

Inactive Ingredients

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

Questions Or Comments

Call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

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

Keep Out of Reach of Children.

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

Package/label Principal Display Panel

NDC : 54738-025-01- 100 CHEW TABS

NDC : 54738-025-03- 1000 CHEW TABS

Structured Label Content

Uses

For the prevention and treatment of nausea, vomiting or dizziness associated with motion sickness. For other uses consult your doctor

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 elarged prostate gland

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

When using this product

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

Directions

take dose one hour before travel starts

tablets can be chewed or swallowed whole with water

adults & children 12 years and over:

take 1-2 tablets once daily

children under 12 years:

ask a doctor

Active Ingredient (Active ingredient)

Meclizine Hydrochloride 25 mg

Other Information (OTHER INFORMATION)

Phenylketonurics:

each tablet contains:

phenylalanine 0.28 mg

store at room temparature 15 - 30 °C

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 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

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

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.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

NDC : 54738-025-01- 100 CHEW TABS

NDC : 54738-025-03- 1000 CHEW TABS

Advanced Ingredient Data

[{"name": "ASPARTAME", "unii": "Z0H242BBR1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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": "RASPBERRY", "unii": "4N14V5R27W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "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": "For the prevention and treatment of nausea, vomiting or dizziness associated with motion sickness. For other uses consult your doctor", "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 elarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product you may get drowsy avoid alcoholic drinks alcohol, sedatives and tranquilizers may increse drowsiness be careful when driving a moor vehicle or operating machinery", "Directions": "take dose one hour before travel starts tablets can be chewed or swallowed whole with water adults & children 12 years and over: take 1-2 tablets once daily children under 12 years: ask a doctor", "Active ingredient": "Meclizine Hydrochloride 25 mg", "OTHER INFORMATION": "Phenylketonurics: each tablet contains: phenylalanine 0.28 mg store at room temparature 15 - 30 °C", "Inactive ingredients": "Aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red 40 (al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor", "Questions or Comments": "Call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away.", "Package/Label Principal Display Panel": "NDC : 54738-025-01- 100 CHEW TABS NDC : 54738-025-03- 1000 CHEW TABS"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:26.104749 · Updated: 2026-03-14T22:54:52.931560