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

Purpose

Antiemetic

Description

Meclizine HCl 12.5mg

Medication Information

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.

Uses

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

Purpose

Antiemetic

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

Description

Meclizine HCl 12.5mg

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

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

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.

Uses

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

Purpose

Antiemetic

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

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

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