meclizine hcl 25 mg chewable tablets

SPL v7

SPL

SPL Set ID a0d519ec-8a3d-4486-8364-e8ed40bef5cb

Route

oral

Published

Effective Date 2011-12-30

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

How Supplied

NDC: 71335-0143-1: 30 Tablets in a BOTTLE NDC: 71335-0143-2: 20 Tablets in a BOTTLE NDC: 71335-0143-3: 25 Tablets in a BOTTLE NDC: 71335-0143-4: 40 Tablets in a BOTTLE NDC: 71335-0143-5: 60 Tablets in a BOTTLE NDC: 71335-0143-6: 90 Tablets in a BOTTLE NDC: 71335-0143-7: 8 Tablets in a BOTTLE NDC: 71335-0143-8: 14 Tablets in a BOTTLE NDC: 71335-0143-9: 10 Tablets in a BOTTLE NDC: 71335-0143-0: 120 Tablets in a BOTTLE

Description

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

Medication Information

Warnings and Precautions

Warnings

Active Ingredient

Active ingredient (in each chewable tablet)

Meclizine HCl, USP 25 mg

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

NDC: 71335-0143-1: 30 Tablets in a BOTTLE

NDC: 71335-0143-2: 20 Tablets in a BOTTLE

NDC: 71335-0143-3: 25 Tablets in a BOTTLE

NDC: 71335-0143-4: 40 Tablets in a BOTTLE

NDC: 71335-0143-5: 60 Tablets in a BOTTLE

NDC: 71335-0143-6: 90 Tablets in a BOTTLE

NDC: 71335-0143-7: 8 Tablets in a BOTTLE

NDC: 71335-0143-8: 14 Tablets in a BOTTLE

NDC: 71335-0143-9: 10 Tablets in a BOTTLE

NDC: 71335-0143-0: 120 Tablets 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 51945-4

Meclizine 25MG Chewable

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

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Active Ingredient (55106-9)

Active ingredient (in each chewable tablet)

Meclizine HCl, USP 25 mg

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

How Supplied (HOW SUPPLIED)

NDC: 71335-0143-1: 30 Tablets in a BOTTLE

NDC: 71335-0143-2: 20 Tablets in a BOTTLE

NDC: 71335-0143-3: 25 Tablets in a BOTTLE

NDC: 71335-0143-4: 40 Tablets in a BOTTLE

NDC: 71335-0143-5: 60 Tablets in a BOTTLE

NDC: 71335-0143-6: 90 Tablets in a BOTTLE

NDC: 71335-0143-7: 8 Tablets in a BOTTLE

NDC: 71335-0143-8: 14 Tablets in a BOTTLE

NDC: 71335-0143-9: 10 Tablets in a BOTTLE

NDC: 71335-0143-0: 120 Tablets in a BOTTLE

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)

Section 51945-4 (51945-4)

Meclizine 25MG Chewable

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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses prevents and treats nausea, vomiting or dizziness due to motion sickness", "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", "34071-1": "Warnings", "42229-5": "DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Drug Facts", "44425-7": "Other information phenylketonurics: contains phenylalanine 0.28 mg per tablet store at room temperature in a dry place", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact the poison control center immediately.", "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", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.", "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", "50570-1": "Do not use in children under 12 years of age unless directed by a doctor.", "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.", "51945-4": "Meclizine 25MG Chewable", "53413-1": "Questions? If you have any questions or comments or to report an adverse event, please contact (800) 795-9775 .", "53414-9": "If pregnant or breast-feeding, ask a health professional before use", "55105-1": "Purpose Antiemetic", "55106-9": "Active ingredient (in each chewable tablet) Meclizine HCl, USP 25 mg", "HOW SUPPLIED": "NDC: 71335-0143-1: 30 Tablets in a BOTTLE NDC: 71335-0143-2: 20 Tablets in a BOTTLE NDC: 71335-0143-3: 25 Tablets in a BOTTLE NDC: 71335-0143-4: 40 Tablets in a BOTTLE NDC: 71335-0143-5: 60 Tablets in a BOTTLE NDC: 71335-0143-6: 90 Tablets in a BOTTLE NDC: 71335-0143-7: 8 Tablets in a BOTTLE NDC: 71335-0143-8: 14 Tablets in a BOTTLE NDC: 71335-0143-9: 10 Tablets in a BOTTLE NDC: 71335-0143-0: 120 Tablets in a BOTTLE"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:07.925366 · Updated: 2026-03-14T23:00:28.895348