Sleepeze Eze Melts_export Only 63029-925-16

Sleepeze Eze Melts_export Only 63029-925-16
SPL v2
SPL
SPL Set ID 685cae75-a977-4028-8414-8ea56f3be06e
Route
ORAL
Published
Effective Date 2024-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Citric Acid Monohydrate Cellulose, Microcrystalline Ethylcelluloses D&c Red No. 7 Hydroxypropyl Cellulose, Unspecified Lactose Monohydrate Mineral Oil Magnesium Stearate Mannitol Stearic Acid Povidone Sucralose Sucrose

Identifiers & Packaging

Pill Appearance
Shape: round Color: pink Size: 13 mm Score: 1
Marketing Status
EXPORT ONLY Active Since 2010-08-03

Description

Drug   Facts

Purpose

Nighttime sleep aid


Medication Information

Purpose

Nighttime sleep aid

Description

Drug   Facts

Uses

● relieves occasional sleeplessness ● helps to reduce difficulty falling asleep

Section 42229-5

Drug   Facts

Directions

●Adults and children 12 years and over: ▪take 1 or 2 tablets at bedtime if needed, or as directed by a doctor ▪if you feel drowsy in the morning, reduce dose to 1 tablet

▪do not take more than directed

Do Not Use

●if you are elderly, as this drug may cause excitation rather than sedation ●with any other product containing diphenhydramine, even one used on skin ●in children under 12 years of age

Questions?

1-800-443-4908

Other Information

 Store at 20° to 25°C

Inactive Ingredients

citric acid, d&c red 7 lake, ethylcellulose, flavour, hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, povidone, stearic acid, sucralose, sucrose

Principal Display Panel

Sleep.eze

25 mg Diphenhydramine Hydrochloride Tablets

16 dissolving tablets

When Using This Product

avoid drinking alcohol.

Stop Use and Ask A Doctor If

sleeplessness continues for more than 2 weeks. Sleeplessness may be a symptom of a serious underlying medical illness.

Keep Out of Reach of Children.

In case of overdose, call a poison control centre or get medical help right away

Active Ingredient (in Each Tablet)

Diphenhydramine Hydrochloride 25 mg

Ask A Doctor Or Pharmacist Before Use If

●have ▪a breathing problem such as emphysema or chronic bronchitis ▪glaucoma ▪difficulty urinating ●take sedatives or tranquilizers ●are pregnant or breastfeeding


Structured Label Content

Uses

● relieves occasional sleeplessness ● helps to reduce difficulty falling asleep

Section 42229-5 (42229-5)

Drug   Facts

Purpose

Nighttime sleep aid

Directions

●Adults and children 12 years and over: ▪take 1 or 2 tablets at bedtime if needed, or as directed by a doctor ▪if you feel drowsy in the morning, reduce dose to 1 tablet

▪do not take more than directed

Do Not Use (Do not use)

●if you are elderly, as this drug may cause excitation rather than sedation ●with any other product containing diphenhydramine, even one used on skin ●in children under 12 years of age

Questions?

1-800-443-4908

Other Information (Other information)

 Store at 20° to 25°C

Inactive Ingredients (Inactive ingredients)

citric acid, d&c red 7 lake, ethylcellulose, flavour, hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, povidone, stearic acid, sucralose, sucrose

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Sleep.eze

25 mg Diphenhydramine Hydrochloride Tablets

16 dissolving tablets

When Using This Product (When using this product)

avoid drinking alcohol.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

sleeplessness continues for more than 2 weeks. Sleeplessness may be a symptom of a serious underlying medical illness.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, call a poison control centre or get medical help right away

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Diphenhydramine Hydrochloride 25 mg

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

●have ▪a breathing problem such as emphysema or chronic bronchitis ▪glaucoma ▪difficulty urinating ●take sedatives or tranquilizers ●are pregnant or breastfeeding


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)