Meclizine Hydrochloride Tablets, Usp 12.5 Mg

Meclizine Hydrochloride Tablets, Usp 12.5 Mg
SPL v2
SPL
SPL Set ID d9cae5a6-8d4b-bdaf-e053-2995a90a7d44
Route
ORAL
Published
Effective Date 2021-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Meclizine (12.5 mg)
Inactive Ingredients
Silicon Dioxide Crospovidone Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance
Imprint: AB;12 Shape: round Color: white Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-14

Description

Meclizine HCl, USP 12.5 mg

Purpose

Antiemetic


Medication Information

Warnings and Precautions

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
Purpose

Antiemetic

Description

Meclizine HCl, USP 12.5 mg

Uses

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

Section 53414-9

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

Warnings

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

Directions
  • dosage should be taken one hour before travel starts
adults and children 12 years and over take 2 or 4 tablets once daily or as directed by a doctor

Drug Facts

Meclizine HCl, USP 12.5 mg

Other Information
  • store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Inactive Ingredients

colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose

Questions Or Comments?

Call 1-844-474-7464 Monday to Friday 8 AM - 5 PM ET

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
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).

Principal Display Panel 12.5 Mg Tablet Label

NDC 68001-528-00

Meclizine Hydrochloride Tablets, USP



12.5 mg

100 Tablets


Structured Label Content

Uses

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

Warnings and Precautions (34071-1)

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
Section 53414-9 (53414-9)

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

Purpose

Antiemetic

Warnings

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

Directions
  • dosage should be taken one hour before travel starts
adults and children 12 years and over take 2 or 4 tablets once daily or as directed by a doctor

Drug Facts

Meclizine HCl, USP 12.5 mg

Other Information
  • store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose

Questions Or Comments? (Questions or comments?)

Call 1-844-474-7464 Monday to Friday 8 AM - 5 PM ET

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
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).

Principal Display Panel 12.5 Mg Tablet Label (PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Label)

NDC 68001-528-00

Meclizine Hydrochloride Tablets, USP



12.5 mg

100 Tablets


Advanced Ingredient Data


Raw Label Data

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