Gc 785

Gc 785
SPL v6
SPL
SPL Set ID 0fce381f-28ef-4591-a569-c5d599a3b95f
Route
ORAL
Published
Effective Date 2013-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Cellulose, Microcrystalline Calcium Phosphate, Dibasic, Anhydrous Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: 93XF;57344 Shape: capsule Color: white Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2004-01-01 Until 2026-12-31

Description

Diphenhydramine Hydrochloride 25mg

Purpose

Nighttime Sleep-aid


Medication Information

Purpose

Nighttime Sleep-aid

Description

Diphenhydramine Hydrochloride 25mg

Uses
  • relieves occasional sleeplessness
Section 50565-1

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

Warnings

Do not use

• in children under 12 years of age

• with any other product containing diphenhydramine, including one used

on skin

Ask a doctor before use if you have

• a breathing problem such as emphysema, asthma, or chronic bronchitis

• glaucoma

• trouble urinating due to an enlarged prostate gland

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

When using this produc t

• avoid alcoholic beverages

• drowsiness will occur

• avoid 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

• adults and children 12 years and over: take two caplets at bedtime if needed, or as directed by a doctor

• do not exceed recommended dose

Package Label

Other Information
  • each caplet contains: calcium 85mg
  • store at 20°C-25°C (68°F-77°F)
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
Inactive Ingredients

calcium phosphate, croscarmellose sodium, magnesium stearate,

microcrystalline cellulose, silica.

Active Ingredient (in Each Caplet)

Diphenhydramine Hydrochloride 25mg


Structured Label Content

Uses
  • relieves occasional sleeplessness
Section 50565-1 (50565-1)

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

Purpose

Nighttime Sleep-aid

Warnings

Do not use

• in children under 12 years of age

• with any other product containing diphenhydramine, including one used

on skin

Ask a doctor before use if you have

• a breathing problem such as emphysema, asthma, or chronic bronchitis

• glaucoma

• trouble urinating due to an enlarged prostate gland

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

When using this produc t

• avoid alcoholic beverages

• drowsiness will occur

• avoid 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

• adults and children 12 years and over: take two caplets at bedtime if needed, or as directed by a doctor

• do not exceed recommended dose

Package Label (package label)

Other Information (Other information)
  • each caplet contains: calcium 85mg
  • store at 20°C-25°C (68°F-77°F)
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
Inactive Ingredients (Inactive ingredients)

calcium phosphate, croscarmellose sodium, magnesium stearate,

microcrystalline cellulose, silica.

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Diphenhydramine Hydrochloride 25mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)