Meclizine Hcl 25 Mg Chewable Tablets

Meclizine Hcl 25 Mg Chewable Tablets
SPL v4
SPL
SPL Set ID ff14ae8b-bc67-4f79-958a-c2d968bfcc30
Route
ORAL
Published
Effective Date 2021-09-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Meclizine (25 mg)
Inactive Ingredients
Aspartame Sucrose Croscarmellose Sodium Dextrose, Unspecified Form Fd&c Red No. 40 Magnesium Stearate Maltodextrin Microcrystalline Cellulose Silicon Dioxide Sodium Sulfate Tricalcium Phosphate

Identifiers & Packaging

Pill Appearance
Imprint: 21G Shape: round Color: pink Size: 8 mm Score: 2
Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-10-15
Description

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Drug Facts

How Supplied

Product: 50436-0994 NDC: 50436-0994-1 30 TABLET, CHEWABLE in a BOTTLE

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

prevents and treats nausea, vomiting or dizziness due to motion sickness

Dosage and Administration

Directions

  • dosage should be taken one hour before travel starts.
  • adults and children 12 years of age and older: Chew 1-2 tablets once daily or as directed by a doctor
  • children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor
How Supplied

Product: 50436-0994

NDC: 50436-0994-1 30 TABLET, CHEWABLE in a BOTTLE

Description

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Drug Facts

Section 42229-5

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

Drug Facts

Section 44425-7

Other information

  • phenylketonurics: contains phenylalanine 0.28 mg per tablet
  • store at room temperature in a dry place
Section 50565-1

Keep out of reach of children.

In case of overdose, get medical help or contact the poison control center immediately.

Section 50567-7

When using this product

  • may cause drowsiness
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • use caution 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 50570-1

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

Section 51727-6

Inactive ingredients Aspartame, croscarmellose sodium, dextrose, FD&C red #40 lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.

Section 53413-1

Questions? If you have any questions or comments or to report an adverse event, please contact (800) 795-9775.

Section 53414-9

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

Section 55105-1

Purpose

Antiemetic

Section 55106-9

Active ingredient (in each chewable tablet)

Meclizine HCl, USP 25 mg

Meclizine Hcl 25 Mg (meclizine Hydrochloride) Tablet, Chewable

Structured Label Content

Indications and Usage (34067-9)

Uses

prevents and treats nausea, vomiting or dizziness due to motion sickness

Dosage and Administration (34068-7)

Directions

  • dosage should be taken one hour before travel starts.
  • adults and children 12 years of age and older: Chew 1-2 tablets once daily or as directed by a doctor
  • children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor
Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

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

Drug Facts

Section 44425-7 (44425-7)

Other information

  • phenylketonurics: contains phenylalanine 0.28 mg per tablet
  • store at room temperature in a dry place
Section 50565-1 (50565-1)

Keep out of reach of children.

In case of overdose, get medical help or contact the poison control center immediately.

Section 50567-7 (50567-7)

When using this product

  • may cause drowsiness
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • use caution 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 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients Aspartame, croscarmellose sodium, dextrose, FD&C red #40 lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.

Section 53413-1 (53413-1)

Questions? If you have any questions or comments or to report an adverse event, please contact (800) 795-9775.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Antiemetic

Section 55106-9 (55106-9)

Active ingredient (in each chewable tablet)

Meclizine HCl, USP 25 mg

How Supplied (HOW SUPPLIED)

Product: 50436-0994

NDC: 50436-0994-1 30 TABLET, CHEWABLE in a BOTTLE

Meclizine Hcl 25 Mg (meclizine Hydrochloride) Tablet, Chewable (MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:44.968196 · Updated: 2026-03-14T22:59:51.166569