Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID b7596293-d30e-4079-ba7c-b387e5eec129
Route
ORAL
Published
Effective Date 2011-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Fd&c Blue No. 1 Microcrystalline Wax Anhydrous Lactose Sodium Starch Glycolate Type A Potato Starch, Corn Dibasic Calcium Phosphate Dihydrate Stearic Acid Silicon Dioxide Magnesium Stearate Hypromelloses Polyethylene Glycols Titanium Dioxide Ethanethiol

Identifiers & Packaging

Pill Appearance
Imprint: RM Shape: round Color: blue Size: 9 mm Score: 2
Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-08-18

Description

Diphenhydramine HCL 25mg

Purpose

Nighttime sleep-aid


Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCL 25mg

Use

helps reduce difficulty falling asleep

Warnings

Do not use

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

Directions
  • adults and children 12 years and older

take 2 tablets at bedtime if needed or as directed by your doctor.

Package Label

Enter section text here

Other Information
  • each tablet contains:calcium 0.2mg
  • store at room temperature
  • avoid excessive heat (greater than 100°F) or humidity

Inactive Ingredients

FDC blue #1, microcrystalline cellulose, lactose anhydrous, sodium starch glycolate, corn starch, dicalcium phosphate, stearic acid, silcon dioxide, magnesium stearate, hypromellose, polyethyleneglycol, titanium dioxide, ethanol

When Using This Product

avoid alcoholic beverages

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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

Active Ingredient (in Each Tablet)

Diphenhydramine HCL 25mg

Ask A Doctor Before Use If You Have
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers


Structured Label Content

Use

helps reduce difficulty falling asleep

Purpose

Nighttime sleep-aid

Warnings

Do not use

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

Directions
  • adults and children 12 years and older

take 2 tablets at bedtime if needed or as directed by your doctor.

Package Label (Package label)

Enter section text here

Other Information (Other information)
  • each tablet contains:calcium 0.2mg
  • store at room temperature
  • avoid excessive heat (greater than 100°F) or humidity

Inactive Ingredients (Inactive ingredients)

FDC blue #1, microcrystalline cellulose, lactose anhydrous, sodium starch glycolate, corn starch, dicalcium phosphate, stearic acid, silcon dioxide, magnesium stearate, hypromellose, polyethyleneglycol, titanium dioxide, ethanol

When Using This Product (When using this product)

avoid alcoholic beverages

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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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

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

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

Diphenhydramine HCL 25mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)