Wal-dram 2 Quick Dissolving (pld)

Wal-dram 2 Quick Dissolving (pld)
SPL v10
SPL
SPL Set ID f3116203-1b8f-438a-b779-7bdd90eaf79e
Route
ORAL
Published
Effective Date 2018-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Meclizine (25 mg)
Inactive Ingredients
Erythritol Mannitol Acesulfame Potassium Hydroxypropyl Cellulose (1600000 Wamw) Ferric Oxide Yellow Sodium Stearyl Fumarate Silicon Dioxide Levomenthol

Identifiers & Packaging

Pill Appearance
Imprint: SJ Shape: round Color: yellow Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-03-01

Description

Active ingredient (in each tablet)  Meclizine hydrochloride 25mg


Medication Information

Warnings and Precautions

​Warnings

Dosage and Administration

Directions

to prevent motion sickness take it at least one hour before traveling    

adults and children 12 years of age and over:  take 1 to 2 (25 to 50 mg) tablets once daily, or as directed by a physician.

Description

Active ingredient (in each tablet)  Meclizine hydrochloride 25mg

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

■ you may get drowsy   ■ avoid alcoholic beverages

■ be careful when driving a motor vehicle or operating machinery

■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect

Section 50568-5

Ask a physician 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

■ difficulty in urination due to enlargement of the prostate gland

Section 50570-1

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

Section 51727-6

Inactive ingredients

acesulfame potassium, erythritol, hydroxypropyl cellulose, colloidal silicon dioxide, mannitol, menthol, sodium stearyl fumarate, yellow ferric oxide.

Section 53414-9

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

Section 55105-1

Purpose

Meclizine hydrochloride    Antiemetic

Section 55106-9

Active ingredient (in each tablet) 

Meclizine hydrochloride 25mg

Section 60561-8

Other information

■ store at 20-30°C (68-86°F)

Carton Image 01


Structured Label Content

Dosage and Administration (34068-7)

Directions

to prevent motion sickness take it at least one hour before traveling    

adults and children 12 years of age and over:  take 1 to 2 (25 to 50 mg) tablets once daily, or as directed by a physician.

Warnings and Precautions (34071-1)

​Warnings

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

■ you may get drowsy   ■ avoid alcoholic beverages

■ be careful when driving a motor vehicle or operating machinery

■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect

Section 50568-5 (50568-5)

Ask a physician 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

■ difficulty in urination due to enlargement of the prostate gland

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients

acesulfame potassium, erythritol, hydroxypropyl cellulose, colloidal silicon dioxide, mannitol, menthol, sodium stearyl fumarate, yellow ferric oxide.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Meclizine hydrochloride    Antiemetic

Section 55106-9 (55106-9)

Active ingredient (in each tablet) 

Meclizine hydrochloride 25mg

Section 60561-8 (60561-8)

Other information

■ store at 20-30°C (68-86°F)

Carton Image 01 (Carton Image -01)


Advanced Ingredient Data


Raw Label Data

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