Sleepeze 50 Mg Minis_export Only 63029-926-16

Sleepeze 50 Mg Minis_export Only 63029-926-16
SPL v2
SPL
SPL Set ID 16f9b5f4-c116-4f1d-9063-be3abb8ac9ee
Route
ORAL
Published
Effective Date 2024-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 1 Aluminum Lake Hypromelloses Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Mineral Oil Silicon Dioxide Stearic Acid Talc Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: S;M Shape: round Color: blue Size: 8 mm Score: 1
Marketing Status
EXPORT ONLY Active Since 2018-12-03

Description

Drug Facts

Purpose

Diphenhydramine Hydrochloride 50 mg…………………………....Nighttime sleep aid


Medication Information

Purpose

Diphenhydramine Hydrochloride 50 mg…………………………....Nighttime sleep aid

Description

Drug Facts

Section 42229-5

Drug Facts

Directions

Adults and children 12 years and over: ▪take 1 tablet at bedtime if needed, or as directed by a doctor ▪if you feel drowsy in the morning, consult a doctor or pharmacist as you may require a lower dosage (25 mg) ▪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

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue no. 1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, mineral oil, silica, stearic acid, talc, titanium dioxide, triacetin

Principal Display Panel

Sleep•eze® MD

extra strength m inis

DIPHENHYDRAMINE HYDROCHLORIDE TABLET S USP 50 mg

extra fort

DIPHÉNHYDRAMINE CHLORHYDRATE EN COMPRIMÉ USP 50 mg

nighttime sleep aid / la solution contre insomnie

16 coated tablets/ comprimes enrobes

DIN 02478757

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

Section 42229-5 (42229-5)

Drug Facts

Purpose

Diphenhydramine Hydrochloride 50 mg…………………………....Nighttime sleep aid

Directions

Adults and children 12 years and over: ▪take 1 tablet at bedtime if needed, or as directed by a doctor ▪if you feel drowsy in the morning, consult a doctor or pharmacist as you may require a lower dosage (25 mg) ▪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)

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue no. 1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, mineral oil, silica, stearic acid, talc, titanium dioxide, triacetin

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Sleep•eze® MD

extra strength m inis

DIPHENHYDRAMINE HYDROCHLORIDE TABLET S USP 50 mg

extra fort

DIPHÉNHYDRAMINE CHLORHYDRATE EN COMPRIMÉ USP 50 mg

nighttime sleep aid / la solution contre insomnie

16 coated tablets/ comprimes enrobes

DIN 02478757

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)