Drug Facts

Drug Facts
SPL v14
SPL
SPL Set ID cf79ac74-017e-4fb4-85d3-4ea944080e89
Route
ORAL
Published
Effective Date 2024-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Meclizine (25 mg)
Inactive Ingredients
Croscarmellose Sodium Dextrose Fd&c Red No. 40 Magnesium Stearate Cellulose, Microcrystalline Silicon Dioxide Saccharin Sodium Stearic Acid Raspberry

Identifiers & Packaging

Pill Appearance
Imprint: PH051 Shape: round Color: pink Size: 8 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-02-01

Description

Meclizine HCl 25mg

Purpose

Antiemetic


Medication Information

Purpose

Antiemetic

Description

Meclizine HCl 25mg

Uses

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

Section 51945-4

MECLIZINE

CHEWABLE

Raspberry Flavor

Warnings

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

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

Directions
  • doage should be taken one hour before travel starts  
Adults and children 12 years and over

take 1 or 2 tablets once daily or as directed by doctor

Other Information
  • Tamper Evident:do not use if seal is broken or missing from bottle.
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients

Croscarmellose sodium, dextrose, FD&C Red#40, raspberry flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium saccharine, stearic acid

Questions Or Comments?

(866) 562-2756 (Mon - Fri, 8AM - 4PM 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 (1-800-222-1222)

Active Ingredient (in Each Tablet)

Meclizine HCl 25mg


Structured Label Content

Uses

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

Section 51945-4 (51945-4)

MECLIZINE

CHEWABLE

Raspberry Flavor

Purpose

Antiemetic

Warnings

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

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

Directions
  • doage should be taken one hour before travel starts  
Adults and children 12 years and over

take 1 or 2 tablets once daily or as directed by doctor

Other Information (Other information)
  • Tamper Evident:do not use if seal is broken or missing from bottle.
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients (Inactive ingredients)

Croscarmellose sodium, dextrose, FD&C Red#40, raspberry flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium saccharine, stearic acid

Questions Or Comments? (Questions or comments?)

(866) 562-2756 (Mon - Fri, 8AM - 4PM 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 (1-800-222-1222)

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Meclizine HCl 25mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)