SPL v2
SPL
SPL Set ID f3c500b9-1fdd-4382-921d-b333d92d34e7
Route
ORAL
Published
Effective Date 2013-02-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Fd&c Blue No. 1 Hydroxypropyl Cellulose Microcrystalline Wax Anhydrous Lactose Sodium Starch Glycolate Type A Potato Stearic Acid Silicon Dioxide Hypromellose 2910 (50 Mpa.s) Polyethylene Glycol 6000 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: BD Shape: round Color: white Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-02-01

Description

Diphenhydramine HCL 25mg

Purpose

Nighttime sleep-aid


Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCL 25mg

Use

helps reduce difficulty falling asleep

Directions
  • adults and children 12 years and older:
take 2 tablets at bedtime if needed or as directed by your doctor.

Do Not Use
  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Package Label

Vida Mia Sleep Aid Original Formula

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

Inactive Ingredients

FD&C blue no. 2, hydroxypropyl cellulose, hypromellose 2910, lactose anhydrous, microcrystalline cellulose, polyethylene glycol 6000, silicic acid anhydride, sodium starch glycolate, stearic acid, titanium dioxide

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

Directions
  • adults and children 12 years and older:
take 2 tablets at bedtime if needed or as directed by your 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
Package Label (Package label)

Vida Mia Sleep Aid Original Formula

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)

FD&C blue no. 2, hydroxypropyl cellulose, hypromellose 2910, lactose anhydrous, microcrystalline cellulose, polyethylene glycol 6000, silicic acid anhydride, sodium starch glycolate, stearic acid, titanium dioxide

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)