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Diphenhyramine Hydrochloride

OTC Oral RxCUI 1049909
Contents

Overview

Active ingredient
Diphenhydramine Hydrochloride
Route
Oral
Label date
2024-04-17

Indications and usage

Uses

  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep

Purpose

Nighttime sleep-aid

Dosage and administration

Directions

  • take only one dose per day (24 hours) adults & children 12 yrs & over 2 softgels at bedtime if needed or as directed by a doctor children under 12 yrs do not use

Warnings

Do not use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin. Do not use
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin. Ask a doctor before use if you have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers 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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Do not use

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

Ask a doctor before use if

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

this product

  • avoid alcoholic beverages

Stop use and ask a doctor if

and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Pregnancy or breast-feeding

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

Active ingredient (label)

(in each softgel) Diphenhydramine HCl 25 mg

Inactive ingredients

s FD&C blue no. 1, FD&C red no. 40, gelatin, polyethylene glycol 400, propylene glycol, purified water, shellac,sorbitol sorbitan solution, titanium dioxide.

Keep out of reach of children

of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.