SPL v1
SPL
SPL Set ID 032a89f2-17e7-45d2-94a1-cc7a601ebdee
Route
ORAL
Published
Effective Date 2025-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

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: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-01

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

Warnings

Do not usein children under 12 years of age unless directed by a doctor.

Do not take 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 if you aretaking 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 a 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 room temperature 20°-25°C (68°-77°F).
Inactive Ingredients

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

Questions Or Comments?

call 1-800-630-8895, 8:30 am - 4:30 pm ET, Monday-Friday

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 (1-800-222-1222).

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)

Purpose

Antiemetic

Warnings

Do not usein children under 12 years of age unless directed by a doctor.

Do not take 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 if you aretaking 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 a 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 room temperature 20°-25°C (68°-77°F).
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

call 1-800-630-8895, 8:30 am - 4:30 pm ET, Monday-Friday

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 (1-800-222-1222).

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

Meclizine HCl 12.5mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)