drug facts

drug facts
SPL v2
SPL
SPL Set ID a23b5195-518e-4093-aea4-10ce96460ee2
Route
oral
Published
Effective Date 2019-04-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (25 mg)
Inactive Ingredients
fd&c red no. 3 gelatin, unspecified lactose, unspecified form magnesium stearate polyethylene glycol 8000 silicon dioxide talc

Identifiers & Packaging

Pill Appearance
Imprint: Dormin;25mg Shape: capsule Color: pink Size: 16 mm Score: 1
Marketing Status
otc monograph final active Since 1992-01-01

Description

Diphenhydramine Hydrochloride


Medication Information

Warnings
  • Do not use
  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Uses
  • helps to reduce difficulty falling asleep
Directions

Adult and children 12 years and over: Take 2 capsules (50 mg) at bedtime if needed or as directed by a doctor

Children under 12 years of age: Do not give this product to children under 12 years of age

Other Information
  • keep in dry place

Use by expiration date on pack

Inactive Ingredients

FD&C Red No. 3, Gelatin, Lactose, Magnesium Stearate, Polyethylene Glycol, Silicon Dioxide, Talc.

Description

Diphenhydramine Hydrochloride

Principal Display Panel

Dormin®

THE NIGHTTIME SLEEP-AID

With Diphenhydramine Hydrochloride

  • FAST
  • SAFE
  • EFFECTIVE

72 Capsules

Stop Use

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

Ask Doctor

As a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to enlarged prostate gland
When Using

When using this product

  • avoid alcoholic drinks
Active Ingredient

Diphenhydramine Hydrochloride

Ask Doctor/pharmacist

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

Pregnancy Or Breast Feeding

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

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings
  • Do not use
  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Uses
  • helps to reduce difficulty falling asleep
Directions

Adult and children 12 years and over: Take 2 capsules (50 mg) at bedtime if needed or as directed by a doctor

Children under 12 years of age: Do not give this product to children under 12 years of age

Other Information
  • keep in dry place

Use by expiration date on pack

Inactive Ingredients

FD&C Red No. 3, Gelatin, Lactose, Magnesium Stearate, Polyethylene Glycol, Silicon Dioxide, Talc.

Principal Display Panel

Dormin®

THE NIGHTTIME SLEEP-AID

With Diphenhydramine Hydrochloride

  • FAST
  • SAFE
  • EFFECTIVE

72 Capsules

Stop Use

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

Ask Doctor

As a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to enlarged prostate gland
When Using

When using this product

  • avoid alcoholic drinks
Active Ingredient (Active ingredient)

Diphenhydramine Hydrochloride

Ask Doctor/pharmacist (Ask Doctor/Pharmacist)

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

Pregnancy Or Breast Feeding (Pregnancy or Breast Feeding)

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

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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