drug facts

drug facts
SPL v1
SPL
SPL Set ID 92445b53-cd51-4bc8-9db9-cbc9d3ea9d4c
Route
oral
Published
Effective Date 2012-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (25 mg)
Inactive Ingredients
fd&c blue no. 1 fd&c red no. 40 gelatin glycerin polyethylene glycol 1000 sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: 602 Shape: capsule Color: purple Size: 16 mm Score: 1
Marketing Status
otc monograph final active Since 2013-10-15

Purpose

Sleep Aid

Description

(in each capsule) Diphenhydramine HCl 25mg


Medication Information

Warnings

Do not use

  • If children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with other drug that cause drowsiness such as antihistamines and nighttime cold/flu products
  • Do not use with generic NyQuil®

Ask a doctor before use if you have:

  • A breathing problem such as asthma, emphysema, or Chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease
  • You are taking a diuretic

    Ask a doctor or pharmacist before use if you are taking sedative or tranquilizers or any other sleep-aid, when using this product :

  • Avoid alcoholic beverages and other drugs that cause drowsiness
  • Drowsiness will occur
  • Be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks.

    Insomnia may be a symptom of serious underlying medical illness.

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

Uses
  • For the relief of occasional sleeplessness
  • Reduces time to fall asleep if have difficulty falling asleep
Purpose

Sleep Aid

Directions

Take only one dose per day (24 hours)- see Overdose warning.

Adults and Children 12 years and over

  • One Dose = Two 25 mg LiquiCaps (50 mg) at bedtime if needed or as directed by a doctor
Other Information
  • Store at 20-25°C (68-77°F)
  • Avoid excessive heat above 40°C(104°F) and high humidity
  • Protect from light
Inactive Ingredients

FD&C Blue No. 1, FD&C Red No. 40, Gelatin, Glycerin, Polyethylene Glycol, Purified Water, Sorbitol, Titanium Dioxide

Description

(in each capsule) Diphenhydramine HCl 25mg

Questions?

Call 1-855-314-1850

TAMPER EVIDENT: This Package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors. 

Active Ingredient

(in each capsule)

Diphenhydramine HCl 25mg

Keep Out of Reach of Children.

Overdose Warning: Taking more than directed can cause serious health problems, In case of overdose, get medical help or contact a Poison Control Center right away.

Package Label.principal Display Panel

NDC: 58805-001-14 LIQUID GELS


Structured Label Content

Warnings

Do not use

  • If children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with other drug that cause drowsiness such as antihistamines and nighttime cold/flu products
  • Do not use with generic NyQuil®

Ask a doctor before use if you have:

  • A breathing problem such as asthma, emphysema, or Chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease
  • You are taking a diuretic

    Ask a doctor or pharmacist before use if you are taking sedative or tranquilizers or any other sleep-aid, when using this product :

  • Avoid alcoholic beverages and other drugs that cause drowsiness
  • Drowsiness will occur
  • Be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks.

    Insomnia may be a symptom of serious underlying medical illness.

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

Uses
  • For the relief of occasional sleeplessness
  • Reduces time to fall asleep if have difficulty falling asleep
Purpose

Sleep Aid

Directions

Take only one dose per day (24 hours)- see Overdose warning.

Adults and Children 12 years and over

  • One Dose = Two 25 mg LiquiCaps (50 mg) at bedtime if needed or as directed by a doctor
Other Information
  • Store at 20-25°C (68-77°F)
  • Avoid excessive heat above 40°C(104°F) and high humidity
  • Protect from light
Inactive Ingredients

FD&C Blue No. 1, FD&C Red No. 40, Gelatin, Glycerin, Polyethylene Glycol, Purified Water, Sorbitol, Titanium Dioxide

Questions?

Call 1-855-314-1850

TAMPER EVIDENT: This Package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors. 

Active Ingredient

(in each capsule)

Diphenhydramine HCl 25mg

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

Overdose Warning: Taking more than directed can cause serious health problems, In case of overdose, get medical help or contact a Poison Control Center right away.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC: 58805-001-14 LIQUID GELS


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)