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

Purpose

Nighttime sleep aid

Description

Drug   Facts


Medication Information

Active Ingredient

Diphenhydramine Hydrochloride 25 mg

Uses

● relieves occasional sleeplessness ● helps to reduce difficulty falling asleep

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

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

Description

Drug   Facts

Principal Display Panel

Sleep.eze

25 mg Diphenhydramine Hydrochloride Tablets

16 dissolving tablets

Questions?

1-800-443-4908

Section 42229-5

Drug   Facts

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

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

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

Active Ingredient (Active ingredient (in each tablet))

Diphenhydramine Hydrochloride 25 mg

Uses

● relieves occasional sleeplessness ● helps to reduce difficulty falling asleep

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

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

Questions?

1-800-443-4908

Section 42229-5 (42229-5)

Drug   Facts

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

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

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)