meclizine 25mg

meclizine 25mg
SPL v2
SPL
SPL Set ID 888c83ef-5392-662b-e053-2a95a90a9682
Route
oral
Published
Effective Date 2019-01-01
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 2019-01-01

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

Active Ingredient

Active ingredient (in each tablet)

Meclizine HCl 25 mg

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 53414-9

If pregnant or breast-feeding,

ask a health professional before use.

Section 55105-1

Purpose

Antiemetic

Package Label.principal Display Panel


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

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

Active Ingredient (55106-9)

Active ingredient (in each tablet)

Meclizine HCl 25 mg

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

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 53414-9 (53414-9)

If pregnant or breast-feeding,

ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Antiemetic

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


Advanced Ingredient Data


Raw Label Data

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