Sleep-aid

Sleep-aid
SPL v6
SPL
SPL Set ID 96a07573-f3bd-528c-e053-2995a90a81c5
Route
ORAL
Published
Effective Date 2020-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Water Fd&c Blue No. 1 Sorbitan Polyethylene Glycol 400 Sorbitol Propylene Glycol Glycerin Gelatin, Unspecified Povidone K30 Fd&c Red No. 40

Identifiers & Packaging

Pill Appearance
Imprint: 784 Shape: oval Color: purple Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-08-20

Description

Diphenhydramine HCl 25mg


Medication Information

Warnings and Precautions

Do not use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with other drugs that cause drowsiness such as antihistamines and night-time cold/flu products

Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as asthma, emphysema or chronic bronchitis
  • heart disease

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep-aid

When using this product

  • drowsiness may occur
  • avoid alcoholic drinks and other drugs that cause drowsiness

Stop use and ask a doctor if

  • sleeplessness persist continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

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

Indications and Usage
  • helps fall asleep faster
  • for relief of occasional sleeplessness
Dosage and Administration

  • do not take more than directed (see overdose warning)
  • adults and children 12 years of age and over: take 2 softgels at bedtime if needed or as directed by doctor
  • children under 12 years of age: do not use

Description

Diphenhydramine HCl 25mg

Section 34088-5

Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Section 50565-1

Keep out of reach of children.

Section 51727-6

polyethylene glycol, propylene glycol, FD&C blue # 1, FD&C red # 40, gelatin, glycerin, sorbitol 70%, povidone, purified water.

Section 51945-4

Section 55105-1

Sleep-aid

Section 55106-9

Diphenhydramine HCl 25mg

Section 60561-8
  • store at room temperature between 20-25°C (68-77ºF).
  • avoid excessive heat, cold and humidity.
  • TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

Structured Label Content

Indications and Usage (34067-9)
  • helps fall asleep faster
  • for relief of occasional sleeplessness
Dosage and Administration (34068-7)

  • do not take more than directed (see overdose warning)
  • adults and children 12 years of age and over: take 2 softgels at bedtime if needed or as directed by doctor
  • children under 12 years of age: do not use

Warnings and Precautions (34071-1)

Do not use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with other drugs that cause drowsiness such as antihistamines and night-time cold/flu products

Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as asthma, emphysema or chronic bronchitis
  • heart disease

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep-aid

When using this product

  • drowsiness may occur
  • avoid alcoholic drinks and other drugs that cause drowsiness

Stop use and ask a doctor if

  • sleeplessness persist continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

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

Section 34088-5 (34088-5)

Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

polyethylene glycol, propylene glycol, FD&C blue # 1, FD&C red # 40, gelatin, glycerin, sorbitol 70%, povidone, purified water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sleep-aid

Section 55106-9 (55106-9)

Diphenhydramine HCl 25mg

Section 60561-8 (60561-8)
  • store at room temperature between 20-25°C (68-77ºF).
  • avoid excessive heat, cold and humidity.
  • TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

Advanced Ingredient Data


Raw Label Data

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