travel sickness

travel sickness
SPL v3
SPL
SPL Set ID cf1332f0-8662-45ed-a76f-3e620f60f05b
Route
oral
Published
Effective Date 2014-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
meclizine (25 mg)
Inactive Ingredients
croscarmellose sodium aspartame magnesium stearate cellulose, microcrystalline sucrose dextrose fd&c red no. 40 raspberry

Identifiers & Packaging

Pill Appearance
Imprint: AP;115 Shape: round Color: red Size: 8 mm Score: 2
Marketing Status
otc monograph final active Since 2008-07-22

Purpose

Antiemetic

Description

(in each tablet) Meclizine HCl 25 mg 


Medication Information

Warnings

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

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 & tranquilizers 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

Purpose

Antiemetic

Directions
  • take dose one hour before travel starts
  • tablets can be chewed or swallowed whole with water
  • adults & children 12 years and over: 1-2 tablets once daily

    children under 12 years: ask a doctor

Other Information
  • phenylketonurics: each tablet contains: phenylalanine 0.28mg
  • store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredients

aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red # 40(Al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor

Description

(in each tablet) Meclizine HCl 25 mg 

Active Ingredient

(in each tablet)

Meclizine HCl 25 mg 

Questions Or Comments

Call 1-800-645-2158, 9 am – 5 pm ET, Monday - Friday

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

Rugby® Duluth, Georgia 30097

Repackaged By :

Aidarex Pharmaceuticals LLC,

Corona, CA 92880

Package Label.principal Display Panel

Meclizine HCl

COMPARE TO ACTIVE INGREDIENT IN BONINE

Meclizine HCl 25 mg (ANTIEMETIC)

NDC 33261-0413-30

30 CHEWABLE TABLETS

Contains Aspartame

Rugby

Duluth, Georgia 30097

Repackaged By :

Aidarex Pharmaceuticals LLC,

Corona, CA 92880


Structured Label Content

Warnings (WARNINGS)

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

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 & tranquilizers 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

Purpose

Antiemetic

Directions
  • take dose one hour before travel starts
  • tablets can be chewed or swallowed whole with water
  • adults & children 12 years and over: 1-2 tablets once daily

    children under 12 years: ask a doctor

Other Information
  • phenylketonurics: each tablet contains: phenylalanine 0.28mg
  • store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredients

aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red # 40(Al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor

Active Ingredient

(in each tablet)

Meclizine HCl 25 mg 

Questions Or Comments (Questions or Comments)

Call 1-800-645-2158, 9 am – 5 pm ET, Monday - Friday

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

Rugby® Duluth, Georgia 30097

Repackaged By :

Aidarex Pharmaceuticals LLC,

Corona, CA 92880

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Meclizine HCl

COMPARE TO ACTIVE INGREDIENT IN BONINE

Meclizine HCl 25 mg (ANTIEMETIC)

NDC 33261-0413-30

30 CHEWABLE TABLETS

Contains Aspartame

Rugby

Duluth, Georgia 30097

Repackaged By :

Aidarex Pharmaceuticals LLC,

Corona, CA 92880


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)