Sleepeze Caplet 50 Mg_export Only 63029-921

Sleepeze Caplet 50 Mg_export Only 63029-921
SPL v2
SPL
SPL Set ID 31d3dcb1-0898-4fee-b236-2f1096b0d787
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
Calcium Phosphate, Dibasic, Dihydrate Cellulose, Microcrystalline Croscarmellose Sodium Fd&c Blue No. 1 Aluminum Lake Hypromelloses Lactose Monohydrate Mineral Oil Magnesium Stearate Silicon Dioxide Stearic Acid Talc Titanium Dioxide Triacetin Water

Identifiers & Packaging

Pill Appearance
Imprint: S;Z Shape: oval Color: blue Size: 13 mm Score: 1
Marketing Status
EXPORT ONLY Active Since 2012-05-23

Description

Drug   Facts

Purpose

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


Medication Information

Purpose

Diphenhydramine Hydrochloride 50 mg………………..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 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

Other Information

 Store at 20° to 25°C

Inactive Ingredients

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

SECURITY   FEATURE:   Safety   sealed   in   individual   pouches.   Do   not   use   if   pouch   is   not   safely   sealed.

Important:   Keep   carton   for   future   reference.

Principal Display Panel

Sleep.eze

Extra strength


Caplets


10 coated capsules

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

Uses

● relieves occasional sleeplessness ● helps to reduce difficulty falling asleep

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

Other Information (Other information)

 Store at 20° to 25°C

Inactive Ingredients (Inactive ingredients)

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

SECURITY   FEATURE:   Safety   sealed   in   individual   pouches.   Do   not   use   if   pouch   is   not   safely   sealed.

Important:   Keep   carton   for   future   reference.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Sleep.eze

Extra strength


Caplets


10 coated capsules

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)