Kroger Nighttime Sleep Aid

Kroger Nighttime Sleep Aid
SPL v5
SPL
SPL Set ID 8b600379-bbec-417d-8924-973eaba3d7d3
Route
ORAL
Published
Effective Date 2019-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Anhydrous Dibasic Calcium Phosphate Fd&c Blue No. 1 Fd&c Blue No. 2 Lecithin, Soybean Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: S5 Shape: capsule Color: blue Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-04-16

Description

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid


Medication Information

Warnings and Precautions

Warnings

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 25 mg

Use

for the relief of occasional sleeplessness

Section 42229-5

Drug Facts (continued)

Section 50565-1

Keep out of reach of children.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking

sedatives or tranquilizers

Section 53413-1

Questions or comments? 1-800-632-6900

Section 53414-9

If pregnant or breast-feeding, ask a health professional

before use.

Directions
 adults and children

12 years and over
 take 2 caplets at bedtime if

needed, or as directed by a

doctor
 children under 12 years  do not use

Do Not Use

■ for children under 12 years of age

■ with any other product containing diphenhydramine,

even one used on skin.

Overdose Warning

In case of overdose, get medical help or contact a

Poison Control Center right away. (1-800-222-1222)

Other Information

each caplet contains: calcium 23.52 mg

■ store between 20-25°C (68-77°F). Avoid high

humidity. Protect from light.

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium,

dicalcium phosphate, FD&C Blue #1, FD&C Blue #2,

lecithin, magnesium stearate, microcrystalline cellulose,

polyethylene glycol, polyvinyl alcohol, talc, titanium

dioxide

Principal Display Panel

COMPARE TO the active ingredient of SIMPLY SLEEP ® NIGHTTIME SLEEP AID CAPLETS*

Kroger

NDC 30142-116-01

Nighttime Sleep-Aid

Diphenhydramine HCl, 25mg

Does NOT contain Pain Reliever

For a Restful

Night's Sleep

SAFE, NON-HABIT FORMING

100

MINI-CAPLETS

actual size

*Simply Sleep® is a registered trademark of Johnson & Johnson, New Brunswick, NJ 08933-7001. Johnson & Johnson is not affiliated with The Kroger Co. or this product.

When Using This Product

■ avoid alcoholic drinks ■ drowsiness will occur

■ do not drive a motor vehicle or operate machinery

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.

Active Ingredient (in Each Caplet)

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have

■ a breathing problem such as emphysema or chronic

bronchitis

■ glaucoma

■ trouble urinating due to an enlarged prostate gland


Structured Label Content

Use

for the relief of occasional sleeplessness

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts (continued)

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking

sedatives or tranquilizers

Section 53413-1 (53413-1)

Questions or comments? 1-800-632-6900

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 and over
 take 2 caplets at bedtime if

needed, or as directed by a

doctor
 children under 12 years  do not use

Do Not Use (Do not use)

■ for children under 12 years of age

■ with any other product containing diphenhydramine,

even one used on skin.

Overdose Warning (Overdose warning)

In case of overdose, get medical help or contact a

Poison Control Center right away. (1-800-222-1222)

Other Information (Other information)

each caplet contains: calcium 23.52 mg

■ store between 20-25°C (68-77°F). Avoid high

humidity. Protect from light.

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium,

dicalcium phosphate, FD&C Blue #1, FD&C Blue #2,

lecithin, magnesium stearate, microcrystalline cellulose,

polyethylene glycol, polyvinyl alcohol, talc, titanium

dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

COMPARE TO the active ingredient of SIMPLY SLEEP ® NIGHTTIME SLEEP AID CAPLETS*

Kroger

NDC 30142-116-01

Nighttime Sleep-Aid

Diphenhydramine HCl, 25mg

Does NOT contain Pain Reliever

For a Restful

Night's Sleep

SAFE, NON-HABIT FORMING

100

MINI-CAPLETS

actual size

*Simply Sleep® is a registered trademark of Johnson & Johnson, New Brunswick, NJ 08933-7001. Johnson & Johnson is not affiliated with The Kroger Co. or this product.

When Using This Product (When using this product)

■ avoid alcoholic drinks ■ drowsiness will occur

■ do not drive a motor vehicle or operate machinery

Stop Use and Ask A Doctor If (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.

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

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

■ a breathing problem such as emphysema or chronic

bronchitis

■ glaucoma

■ trouble urinating due to an enlarged prostate gland


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)