Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID 8b3c9283-b618-4d57-9f15-7cf73e8737f5

Route

ORAL

Published

Effective Date 2025-12-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Meclizine (12.5 mg)

Inactive Ingredients

Croscarmellose Sodium Calcium Phosphate, Dibasic, Anhydrous Magnesium Stearate Cellulose, Microcrystalline Silicon Dioxide Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: PH049 Shape: capsule Color: white Size: 13 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2018-02-01

Description

Meclizine HCl 12.5mg

Purpose

Antiemetic

Medication Information

Purpose

Antiemetic

Description

Meclizine HCl 12.5mg

Uses

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

Section 51945-4

PHARBEST

NDC 16103-386-08

Manufactured in the USA

Motion Sickness Relief

MECLIZINE

Meclizine HCl 12.5 mg

Anti-Emetic

• Motion Sickness • Nausea • Vomiting

100 CAPLETS

Warnings

Do not use for 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
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis

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

Directions

dosage should be taken 1 hour before travel starts

Adults and children 12 years and over

take 2 or 4 caplets once daily or as directed by doctor

Other Information

Tamper Evident: do not use if safety seal under cap is broken or missing
each caplet contains: calcium 28 mg
store at 20°-25°C (68°-77°F), excursions permitted between 15-30°C(59-86°F)

Inactive Ingredients

Croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, 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 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 right away (800-222-1222).

Active Ingredient (in Each Caplet)

Meclizine HCl 12.5mg

Structured Label Content

Uses

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

Section 51945-4 (51945-4)

PHARBEST

NDC 16103-386-08

Manufactured in the USA

Motion Sickness Relief

MECLIZINE

Meclizine HCl 12.5 mg

Anti-Emetic

• Motion Sickness • Nausea • Vomiting

100 CAPLETS

Purpose

Antiemetic

Warnings

Do not use for 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
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis

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

Directions

dosage should be taken 1 hour before travel starts

Adults and children 12 years and over

take 2 or 4 caplets once daily or as directed by doctor

Other Information (Other information)

Tamper Evident: do not use if safety seal under cap is broken or missing
each caplet contains: calcium 28 mg
store at 20°-25°C (68°-77°F), excursions permitted between 15-30°C(59-86°F)

Inactive Ingredients (Inactive ingredients)

Croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, 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 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 right away (800-222-1222).

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Meclizine HCl 12.5mg

Advanced Ingredient Data

[{"name": "MECLIZINE", "unii": "3L5TQ84570", "classCode": "ACTIB", "strengthNumerator": "12.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS", "unii": "L11K75P92J", "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": "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 16103-386-08 Manufactured in the USA Motion Sickness Relief MECLIZINE Meclizine HCl 12.5 mg Anti-Emetic • Motion Sickness • Nausea • Vomiting 100 CAPLETS", "Purpose": "Antiemetic", "Warnings": "Do not use for 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 trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.", "Directions": "dosage should be taken 1 hour before travel starts Adults and children 12 years and over take 2 or 4 caplets once daily or as directed by doctor", "Other information": "Tamper Evident: do not use if safety seal under cap is broken or missing each caplet contains: calcium 28 mg store at 20°-25°C (68°-77°F), excursions permitted between 15-30°C(59-86°F)", "Inactive ingredients": "Croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, 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 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 right away (800-222-1222).", "Active ingredient (in each caplet)": "Meclizine HCl 12.5mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:54.216487 · Updated: 2026-03-14T23:11:53.041179