4483-333 - Motion Time

4483-333 - Motion Time
SPL v3
SPL
SPL Set ID 7f3ce1e6-c0d6-4b56-8f7a-6368eb46901f
Route
ORAL
Published
Effective Date 2011-01-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Meclizine (25 mg)
Inactive Ingredients
Anhydrous Lactose Crospovidone Dextrose Fd&c Red No. 40 Magnesium Stearate Cellulose, Microcrystalline Modified Corn Starch (1-octenyl Succinic Anhydride) Propylene Glycol Raspberry Silicon Dioxide Saccharin Sodium Stearic Acid Talc Vanilla

Identifiers & Packaging

Pill Appearance
Imprint: TCL333 Shape: round Color: pink Size: 9 mm Score: 2
Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-08-09

Description

Active ingredient (in each tablet) Meclizine HCl 25 mg


Medication Information

Warnings and Precautions

Warnings

Do not give to children under 12 years of age unless directed by a doctor

Indications and Usage

Uses

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

Dosage and Administration

Directions

  • dosage should be taken one hour before travel starts
  • adults and children 12 years of age and over: take 1 to 2 tablets once daily or as directed by a doctor

Description

Active ingredient (in each tablet) Meclizine HCl 25 mg

Section 44425-7

Other information

  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) in a dry place
  • use by expiration date on package
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 50567-7

When using this product

  • do not exceed recommended dosage
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Section 50569-3

Do not take unless directed by a doctor if you have

  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis

Section 50570-1

Do not take if you are

taking sedatives or tranquilizers, without first consulting your doctor

Section 51727-6

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, crospovidone, dextrose, FD-C red 40 aluminum lake, magnesium stearate, microcrystalline cellulose, modified corn starch, propylene glycol, raspberry flavor, silicon dioxide, sodium saccharin, stearic acid, talc, vanilla flavor

Section 51945-4

Meclizine HCL Chewable Tablets

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 tablet)

Meclizine HCl 25 mg


Structured Label Content

Indications and Usage (34067-9)

Uses

prevents and treats nausea, vomiting, or dizziness associated with 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 over: take 1 to 2 tablets once daily or as directed by a doctor

Warnings and Precautions (34071-1)

Warnings

Do not give to children under 12 years of age unless directed by a doctor

Section 44425-7 (44425-7)

Other information

  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) in a dry place
  • use by expiration date on package
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 50567-7 (50567-7)

When using this product

  • do not exceed recommended dosage
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Section 50569-3 (50569-3)

Do not take unless directed by a doctor if you have

  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis

Section 50570-1 (50570-1)

Do not take if you are

taking sedatives or tranquilizers, without first consulting your doctor

Section 51727-6 (51727-6)

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, crospovidone, dextrose, FD-C red 40 aluminum lake, magnesium stearate, microcrystalline cellulose, modified corn starch, propylene glycol, raspberry flavor, silicon dioxide, sodium saccharin, stearic acid, talc, vanilla flavor

Section 51945-4 (51945-4)

Meclizine HCL Chewable Tablets

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 tablet)

Meclizine HCl 25 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)