Meclizine Hcl 12.5

Meclizine Hcl 12.5
SPL v3
SPL
SPL Set ID 3ffa63f2-ea06-4be0-9f59-162c2a9604fc
Route
ORAL
Published
Effective Date 2025-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Meclizine (12.5 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Magnesium Stearate Stearic Acid Microcrystalline Cellulose Anhydrous Dibasic Calcium Phosphate

Identifiers & Packaging

Pill Appearance
Imprint: AP;117 Shape: oval Color: white Size: 13 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-11-01

Description

Meclizine HCL 12.5 mg

Purpose

Antiemetic


Medication Information

Purpose

Antiemetic

Description

Meclizine HCL 12.5 mg

Uses
  • prevents and treats nausea, vomiting, or dizziness due to motion sickness
  • for other uses, consult your doctor
Section 42229-5

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product

  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 50569-3

Ask a doctor before use if you have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
Section 51945-4

NDC 71205-762-90

Meclizine HCL 12.5 mg

ANTIEMETIC

90 CAPLETS

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

Ask a docotor before use if you have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • 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.

Directions
  • adults & children 12 years and over: 2-4 caplets once daily
  • children under 12 years: ask a doctor
Other Information
  • each caplet contains: calcium 51 mg
  • store at room temperature 15º-30ºC (59º-86ºF)
  • This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.
Inactive Ingredients

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

Questions Or Comments?

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

Active Ingredient (in Each Caplet)

Meclizine HCL 12.5 mg


Structured Label Content

Uses
  • prevents and treats nausea, vomiting, or dizziness due to motion sickness
  • for other uses, consult your doctor
Section 42229-5 (42229-5)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product

  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
Section 51945-4 (51945-4)

NDC 71205-762-90

Meclizine HCL 12.5 mg

ANTIEMETIC

90 CAPLETS

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Antiemetic

Warnings

Ask a docotor before use if you have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • 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.

Directions
  • adults & children 12 years and over: 2-4 caplets once daily
  • children under 12 years: ask a doctor
Other Information (Other information)
  • each caplet contains: calcium 51 mg
  • store at room temperature 15º-30ºC (59º-86ºF)
  • This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

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

Meclizine HCL 12.5 mg


Advanced Ingredient Data


Raw Label Data

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