Zzzsleep Diphenhydramine Hcl

Zzzsleep Diphenhydramine Hcl
SPL v1
SPL
SPL Set ID 3eb097a8-bdec-484e-9fad-5b141ef0a5af
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

Description

(in each tablet) Diphenhydramine HCl 25mg

Purpose

Sleep Aid


Medication Information

Purpose

Sleep Aid

Description

(in each tablet) Diphenhydramine HCl 25mg

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

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
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 tablet)

Diphenhydramine HCl 25mg

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

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: 76168-066-02 –12 LIQUID GELS

Not for treating cold or flu – see warnings


Structured Label Content

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

Sleep Aid

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.

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
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 tablet)

Diphenhydramine HCl 25mg

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

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: 76168-066-02 –12 LIQUID GELS

Not for treating cold or flu – see warnings


Advanced Ingredient Data


Raw Label Data

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