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

Active Ingredient

Active ingredient (in each tablet) 

Meclizine hydrochloride 25mg

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 60561-8

Other information

■ store at 20-30°C (68-86°F)

Carton Image 01


Structured Label Content

Warnings and Precautions (34071-1)

​Warnings

Active Ingredient (55106-9)

Active ingredient (in each tablet) 

Meclizine hydrochloride 25mg

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.

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 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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