Res - 1091 - 2019-1014 - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Silicon Dioxide Croscarmellose Sodium Calcium Phosphate, Dibasic, Anhydrous Fd&c Blue No. 1 Hypromellose, Unspecified Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Polysorbate 80 Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 25;052 Shape: oval Color: blue Size: 11 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2018-10-05

Medication Information

Purpose

Nighttime sleep-aid

Description

Drug Facts

Use

for relief of occasional sleeplessness

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Section 50567-7

When using this product avoid alcoholic drinks

Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 50569-3

Ask a doctor before use if you have

a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland
glaucoma

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions

adults and children 12 years of age and over	take 2 caplets at bedtime if needed, or as directed by a doctor
children under 12 years of age	do not use

Do Not Use

with any other product containing diphenhydramine, even one used on skin
in children under 12 years of age

Other Information

each caplet contains: calcium 45 mg
store at room temperature 15°-30°C (59°-86°F)
retain carton for complete product information

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C blue #1, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Active Ingredient (in Each Caplet)

Diphenhydramine HCl 25 mg

Principal Display Panel 24 Caplet Carton

RESTORE U

NDC 57344-091-03

^†COMPARE TO THE ACTIVE INGREDIENT IN SIMPLY SLEEP ^®

Rest Simply

actual size

Diphehydramine HCl

Nighttime Sleep-Aid

Helps You Fall Asleep Fast, Non-Habit Forming, Use as Directed

100 CAPLETS - 25 MG EACH

Structured Label Content

Use

for relief of occasional sleeplessness

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Section 50567-7 (50567-7)

When using this product avoid alcoholic drinks

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 50569-3 (50569-3)

Ask a doctor before use if you have

a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland
glaucoma

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Nighttime sleep-aid

Directions

adults and children 12 years of age and over	take 2 caplets at bedtime if needed, or as directed by a doctor
children under 12 years of age	do not use

Do Not Use (Do not use)

with any other product containing diphenhydramine, even one used on skin
in children under 12 years of age

Other Information (Other information)

each caplet contains: calcium 45 mg
store at room temperature 15°-30°C (59°-86°F)
retain carton for complete product information

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C blue #1, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Diphenhydramine HCl 25 mg

Principal Display Panel 24 Caplet Carton (PRINCIPAL DISPLAY PANEL - 24 Caplet Carton)

RESTORE U

NDC 57344-091-03

^†COMPARE TO THE ACTIVE INGREDIENT IN SIMPLY SLEEP ^®

Rest Simply

actual size

Diphehydramine HCl

Nighttime Sleep-Aid

Helps You Fall Asleep Fast, Non-Habit Forming, Use as Directed

100 CAPLETS - 25 MG EACH

Advanced Ingredient Data

[{"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS", "unii": "L11K75P92J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Use": "for relief of occasional sleeplessness", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.", "50567-7": "When using this product avoid alcoholic drinks", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers", "50569-3": "Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Nighttime sleep-aid", "Directions": "adults and children 12 years of age and over take 2 caplets at bedtime if needed, or as directed by a doctor children under 12 years of age do not use", "Do not use": "with any other product containing diphenhydramine, even one used on skin in children under 12 years of age", "Other information": "each caplet contains: calcium 45 mg store at room temperature 15°-30°C (59°-86°F) retain carton for complete product information", "Inactive ingredients": "colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C blue #1, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide", "Active ingredient (in each caplet)": "Diphenhydramine HCl 25 mg", "PRINCIPAL DISPLAY PANEL - 24 Caplet Carton": "RESTORE U NDC 57344-091-03 † COMPARE TO THE ACTIVE INGREDIENT IN SIMPLY SLEEP ® Rest Simply actual size Diphehydramine HCl Nighttime Sleep-Aid Helps You Fall Asleep Fast, Non-Habit Forming, Use as Directed 100 CAPLETS - 25 MG EACH"}

Res - 1091 - 2019-1014

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information