Sleepeze Gelcaps 50 Mg_export Only 63029-927-20

Sleepeze Gelcaps 50 Mg_export Only 63029-927-20
SPL v2
SPL
SPL Set ID 2ff54df4-2fb8-4d9d-a363-316c9885f713
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
Fd&c Blue No. 1 Gelatin Glycerin Polyethylene Glycol, Unspecified Sorbitol Water

Identifiers & Packaging

Pill Appearance
Imprint: P50 Shape: oval Color: blue Size: 1 mm Score: 1
Marketing Status
EXPORT ONLY Active Since 2012-05-23

Description

Drug Facts

Purpose

Nighttime sleep aid


Medication Information

Purpose

Nighttime sleep aid

Description

Drug Facts

Uses

● relieves occasional sleeplessness

Section 42229-5

Drug Facts

Directions

Adults and children 12 years and over: ▪take 1 capsule 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

.

Active Ingredient

Diphenhydramine Hydrochloride 50 mg

Other Information

Store at 20° to 25°C

Inactive Ingredients

FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, sorbitan, sorbitol, water

Principal Display Panel

Sleep•eze® MD

extra strength

gelcaps

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES 50 mg

20 soft gel capsules

DIN 02238644

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 You

●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

Section 42229-5 (42229-5)

Drug Facts

Purpose

Nighttime sleep aid

Directions

Adults and children 12 years and over: ▪take 1 capsule 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

.

Active Ingredient (Active ingredient)

Diphenhydramine Hydrochloride 50 mg

Other Information (Other information)

Store at 20° to 25°C

Inactive Ingredients (Inactive ingredients)

FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, sorbitan, sorbitol, water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Sleep•eze® MD

extra strength

gelcaps

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES 50 mg

20 soft gel capsules

DIN 02238644

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 You (Ask a doctor or pharmacist before use if you)

●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

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