sleepeze 50 mg minis_export only 63029-926-16

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

Medication Information

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

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

Description

Drug Facts

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

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

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)

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

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

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIBASIC CALCIUM PHOSPHATE DIHYDRATE", "unii": "O7TSZ97GEP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1 ALUMINUM LAKE", "unii": "J9EQA3S2JM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIACETIN", "unii": "XHX3C3X673", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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": "●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"}

sleepeze 50 mg minis_export only 63029-926-16

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information