SPL v3
SPL
SPL Set ID e0459e71-32dd-4715-b103-bb14db42c5f3
Route
ORAL
Published
Effective Date 2023-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin Propylene Glycol Water Sodium Benzoate Sodium Citrate Stevia Leaf Sucralose Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-01

Description

(in each 3mL) (one dose) Diphenhydramine HCI, 50 mg

Purpose

Nighttime sleep-aid


Medication Information

Purpose

Nighttime sleep-aid

Dosage and Administration

​Directions

  • only use this product according to these directions or as directed by a doctor
  • do not exceed 1 dose (3 mL) (50 mg) in any24-hour period
  • measure only 3 mL with dosing syringe provided
  • keep dosing syringe with product
  • mL = milliliter - fl oz = fluid ounce

age dose
adults and children 12 years and over

3mL at bedtime

children under 12 years do not use

Description

(in each 3mL) (one dose) Diphenhydramine HCI, 50 mg

Uses
  • For relief of occasional sleeplessness.
  • Helps to reduce difficulty falling asleep.
  • Reduces time to fall asleep. Warnings
Warning

Do not use

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

Do not take this product, unless directed by a doctor

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

Do not take this product ifyou are taking sedatives or tranquilizers, without first consulting your doctor. Avoid alcoholic beverages while taking this product. If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness.



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



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

Product Label
Active Ingredient

(in each 3mL) (one dose) Diphenhydramine HCI, 50 mg

Other Information 

TAMPER EVIDENT: Do not use if seal on the bottle is broken.

store at 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients

citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, stevia, sucralose, sucrose

Questions Or Comments?

Call 1-833-289-7626 between 10 a.m. to 4 p.m. CST, Monday through Friday or visit our website www.InstaRelief.com to report serious adverse events associated with the use of this product. Please call a doctor for medical advice.


Structured Label Content

Uses
  • For relief of occasional sleeplessness.
  • Helps to reduce difficulty falling asleep.
  • Reduces time to fall asleep. Warnings
Dosage and Administration (34068-7)

​Directions

  • only use this product according to these directions or as directed by a doctor
  • do not exceed 1 dose (3 mL) (50 mg) in any24-hour period
  • measure only 3 mL with dosing syringe provided
  • keep dosing syringe with product
  • mL = milliliter - fl oz = fluid ounce

age dose
adults and children 12 years and over

3mL at bedtime

children under 12 years do not use

Purpose

Nighttime sleep-aid

Warning

Do not use

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

Do not take this product, unless directed by a doctor

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

Do not take this product ifyou are taking sedatives or tranquilizers, without first consulting your doctor. Avoid alcoholic beverages while taking this product. If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness.



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



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

Product Label (Product label)
Active Ingredient (Active ingredient)

(in each 3mL) (one dose) Diphenhydramine HCI, 50 mg

Other Information  (Other information )

TAMPER EVIDENT: Do not use if seal on the bottle is broken.

store at 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients (Inactive ingredients)

citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, stevia, sucralose, sucrose

Questions Or Comments? (Questions or comments?)

Call 1-833-289-7626 between 10 a.m. to 4 p.m. CST, Monday through Friday or visit our website www.InstaRelief.com to report serious adverse events associated with the use of this product. Please call a doctor for medical advice.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)