Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID 99b87792-f0b8-458f-9316-0d0c9e1d1684

Route

ORAL

Published

Effective Date 2020-05-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Meclizine (12.5 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

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

Marketing Status

OTC MONOGRAPH FINAL Active Since 2018-02-01

Description

Meclizine HCl 12.5mg

Purpose

Antiemetic

How Supplied

Product: 50090-3017 NDC: 50090-3017-3 30 TABLET in a BOTTLE NDC: 50090-3017-7 28 TABLET in a BOTTLE NDC: 50090-3017-8 90 TABLET in a BOTTLE

Medication Information

Purpose

Antiemetic

How Supplied

Product: 50090-3017

NDC: 50090-3017-3 30 TABLET in a BOTTLE

NDC: 50090-3017-7 28 TABLET in a BOTTLE

NDC: 50090-3017-8 90 TABLET in a BOTTLE

Description

Meclizine HCl 12.5mg

Uses

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

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

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

Questions?

Adverse drug event call (866) 562-2756 (M - F, 8AM - 4PM EST).

Other Information

Tamper Evident: do not use if safety seal under cap is broken or missing
store at room temperature 20°-25°C (68°-77°F)

Inactive Ingredients

Croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Meclizine Hcl 12.5 Mg

When Using This Product

do not exceed recommended dosage
drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
be careful 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.

Active Ingredient (in Each Caplet)

Meclizine HCl 12.5mg

Structured Label Content

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

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

Questions?

Adverse drug event call (866) 562-2756 (M - F, 8AM - 4PM EST).

How Supplied (HOW SUPPLIED)

Product: 50090-3017

NDC: 50090-3017-3 30 TABLET in a BOTTLE

NDC: 50090-3017-7 28 TABLET in a BOTTLE

NDC: 50090-3017-8 90 TABLET in a BOTTLE

Other Information (Other information)

Tamper Evident: do not use if safety seal under cap is broken or missing
store at room temperature 20°-25°C (68°-77°F)

Inactive Ingredients (Inactive ingredients)

Croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Meclizine Hcl 12.5 Mg (Meclizine HCl 12.5 mg)

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
be careful 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.

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": "ANHYDROUS DIBASIC CALCIUM PHOSPHATE", "unii": "L11K75P92J", "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": "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", "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": "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", "Questions?": "Adverse drug event call (866) 562-2756 (M - F, 8AM - 4PM EST).", "HOW SUPPLIED": "Product: 50090-3017 NDC: 50090-3017-3 30 TABLET in a BOTTLE NDC: 50090-3017-7 28 TABLET in a BOTTLE NDC: 50090-3017-8 90 TABLET in a BOTTLE", "Other information": "Tamper Evident: do not use if safety seal under cap is broken or missing store at room temperature 20°-25°C (68°-77°F)", "Inactive ingredients": "Croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid", "When using this product": "do not exceed recommended dosage drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful 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.", "Active ingredient (in each caplet)": "Meclizine HCl 12.5mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:31.284123 · Updated: 2026-03-14T22:56:43.455577