meclizine hcl 12.5

meclizine hcl 12.5
SPL v6
SPL
SPL Set ID 32832b0f-0b38-27ce-e054-00144ff8d46c
Route
oral
Published
Effective Date 2015-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
meclizine (12.5 mg)
Inactive Ingredients
croscarmellose sodium magnesium stearate stearic acid silicon dioxide cellulose, microcrystalline calcium phosphate, dibasic, anhydrous

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

Purpose

Antiemetic

Description

Meclizine HCL 12.5 mg


Medication Information

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 tranquillizers 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.

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

Antiemetic

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

Description

Meclizine HCL 12.5 mg

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 prodcut

  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives and tranqulizers 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 69618-027-10

Meclizine HCL 12.5 mg

ANTIEMETIC

1000 CAPLETS

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Section 53414-9

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

Questions Or Comments?

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

Active Indredient (in Each Caplet)

Meclizine HCL 12.5 mg


Structured Label Content

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 tranquillizers 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.

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

Antiemetic

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

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 prodcut

  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives and tranqulizers 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 69618-027-10

Meclizine HCL 12.5 mg

ANTIEMETIC

1000 CAPLETS

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Section 53414-9 (53414-9)

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

Questions Or Comments? (Questions or comments?)

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

Active Indredient (in Each Caplet) (Active indredient (in each caplet))

Meclizine HCL 12.5 mg


Advanced Ingredient Data


Raw Label Data

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