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

Purpose

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

Description

Drug   Facts


Medication Information

Uses

● relieves occasional sleeplessness ● helps to reduce difficulty falling asleep

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

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.

Description

Drug   Facts

Principal Display Panel

Sleep.eze

Extra strength


Caplets


10 coated capsules

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

Uses

● relieves occasional sleeplessness ● helps to reduce difficulty falling asleep

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

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

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)