032a89f2-17e7-45d2-94a1-cc7a601ebdee

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

Purpose

Antiemetic

Description

Meclizine HCl 12.5mg


Medication Information

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.

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 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.

Description

Meclizine HCl 12.5mg

Section 51945-4

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

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.

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 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.

Section 51945-4 (51945-4)

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

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