Qch - 1019- 2019-1004

Qch - 1019- 2019-1004
SPL v5
SPL
SPL Set ID 5fab9bd4-66d7-4356-a778-8900b2e270e2
Route
ORAL
Published
Effective Date 2019-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Calcium Phosphate, Dibasic, Anhydrous Fd&c Blue No. 1 Aluminum Oxide Magnesium Stearate Cellulose, Microcrystalline

Identifiers & Packaging

Pill Appearance
Imprint: 93XF;57344 Shape: round Color: blue Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2007-06-25 Until 2027-04-30

Description

Drug Facts

Purpose

Nighttime sleep-aid


Medication Information

Purpose

Nighttime sleep-aid

Description

Drug Facts

Use

helps to reduce difficulty falling asleep

Section 42229-5

Drug Facts

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 53414-9

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

Directions
  • adults and children 12 years of age and over: take two tablets at bedtime if needed, or as directed by a doctor
Do Not Use
  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Other Information
  • each tablet contains: calcium 85 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, magnesium stearate, microcrystalline cellulose

Principal Display Panel

NDC 63868-611-32

QUALITY CHOICE

†Compare to SOMINEX® active ingredient

Nighttime Sleep Aid

Original Formula

Diphenhydramine HCl, 25mg

Get to sleep safely, wake up refreshed

32 Tablets

Keep Out of Reach of Children.

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

Active Ingredient (in Each Tablet)

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

helps to reduce difficulty falling asleep

Section 42229-5 (42229-5)

Drug Facts

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 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 two tablets at bedtime if needed, or as directed by a doctor
Do Not Use (Do not use)
  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Other Information (Other information)
  • each tablet contains: calcium 85 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, magnesium stearate, microcrystalline cellulose

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 63868-611-32

QUALITY CHOICE

†Compare to SOMINEX® active ingredient

Nighttime Sleep Aid

Original Formula

Diphenhydramine HCl, 25mg

Get to sleep safely, wake up refreshed

32 Tablets

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

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)