SPL v3
SPL
SPL Set ID d7419e82-55d7-4699-a2d5-c45c54f845c7
Route
ORAL
Published
Effective Date 2021-04-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Meclizine (25 mg)
Inactive Ingredients
Anhydrous Lactose Silicon Dioxide Starch, Corn D&c Yellow No. 10 Magnesium Stearate Microcrystalline Cellulose Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance
Imprint: TCL;086 Shape: round Color: yellow Size: 9 mm Score: 2
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-09-01
Description

Drug Facts

Purpose

Antiemetic

How Supplied

Product: 50090-4493 NDC: 50090-4493-0 2 TABLET in a PACKET / 500 in a BOX

Medication Information

Purpose

Antiemetic

How Supplied

Product: 50090-4493

NDC: 50090-4493-0 2 TABLET in a PACKET / 500 in a BOX

Description

Drug Facts

Uses

For the prevention and treatment of the nausea, vomiting, or dizziness associated with motion sickness.

Section 42229-5

Drug Facts

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 53414-9

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

Directions
  • do not use more than directed
  • to prevent motion sickness, take the first dose one hour before starting activity
Do Not Use
  • for children under 12 years of age unless directed by a doctor
  • for frequent or prolonged use except under the advice of a doctor
If You Are
  • taking sedatives or tranquilizers
Other Information
  • store at room temperature 59- 86º F (15-30ºC)
  • tamper-evident sealed packets
  • do not use any opened or torn packets
Inactive Ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch, D&C yellow # 10, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions Or Comments?

1-800-634-7680

Meclizine Hydrochloride
When Using This Product
  • drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages while taking this product
  • use caution when driving a motor vehicle or operating machinery

Do not exceed recommended dosage.

Active Ingredient (in Each Tablet)

Meclizine Hydrochloride 25 mg

Ask A Doctor Before Use If You Have
  • breathing problems such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Structured Label Content

Uses

For the prevention and treatment of the nausea, vomiting, or dizziness associated with motion sickness.

Section 42229-5 (42229-5)

Drug Facts

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 53414-9 (53414-9)

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

Purpose

Antiemetic

Directions
  • do not use more than directed
  • to prevent motion sickness, take the first dose one hour before starting activity
Do Not Use (Do not use)
  • for children under 12 years of age unless directed by a doctor
  • for frequent or prolonged use except under the advice of a doctor
If You Are (if you are)
  • taking sedatives or tranquilizers
How Supplied (HOW SUPPLIED)

Product: 50090-4493

NDC: 50090-4493-0 2 TABLET in a PACKET / 500 in a BOX

Other Information (Other information)
  • store at room temperature 59- 86º F (15-30ºC)
  • tamper-evident sealed packets
  • do not use any opened or torn packets
Inactive Ingredients (Inactive ingredients)

anhydrous lactose, colloidal silicon dioxide, corn starch, D&C yellow # 10, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions Or Comments? (Questions or comments?)

1-800-634-7680

Meclizine Hydrochloride (MECLIZINE HYDROCHLORIDE)
When Using This Product (When using this product)
  • drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages while taking this product
  • use caution when driving a motor vehicle or operating machinery

Do not exceed recommended dosage.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Meclizine Hydrochloride 25 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • breathing problems such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:31.427746 · Updated: 2026-03-14T22:59:31.191887