SPL v1
SPL
SPL Set ID 2c4e0d5e-958d-4274-876a-52126c795c0f
Route
ORAL
Published
Effective Date 2012-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Stearic Acid Polyvinyl Alcohol, Unspecified Starch, Corn Calcium Phosphate, Dibasic, Anhydrous Silicon Dioxide D&c Red No. 27 Cellulose, Microcrystalline Magnesium Stearate Polyethylene Glycol, Unspecified Titanium Dioxide Talc

Identifiers & Packaging

Pill Appearance
Imprint: 44;329 Shape: oval Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-04-01

Description

Diphenhydramine Hydrochloride 25mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Diphenhydramine Hydrochloride 25mg

Uses
  • temporarily relieves these symptoms due to hay fever and other upper respiratory allergies:
  • runny nose

  • sneezing

  • itching of the nose and throat
  • itchy, watery eyes
Section 50565-1

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

Section 51945-4

Warnings

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

When using this product

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery

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

Directions
  • do not exceed recommended dose
  • adults and children 12 years and over, take 1 to 2 tablets every 4-6 hours, as needed; not more than 12 tablets in 24 hours, or as directed by a doctor
  • children under 12 years: ask a doctor
Other Information
  • each tablet contains: calcium 30 mg
  • store at 20-25°C (68-77°F); excursions permitted between 15°C - 30°C (59°F - 86°F)
  • protect from moisture • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
Inactive Ingredients

cellulose, D&C red #27 lake, dicalcium phosphate, magnesium stearate, PEG, polyvinyl alcohol, silica, starch, stearic acid, talc, titanium dioxide

Questions Or Comments?

1-800-540-3765

Active Ingredient (in Each Tablet)

Diphenhydramine Hydrochloride 25mg


Structured Label Content

Uses
  • temporarily relieves these symptoms due to hay fever and other upper respiratory allergies:
  • runny nose

  • sneezing

  • itching of the nose and throat
  • itchy, watery eyes
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.

Section 51945-4 (51945-4)

Purpose

Antihistamine

Warnings

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

When using this product

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery

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

Directions
  • do not exceed recommended dose
  • adults and children 12 years and over, take 1 to 2 tablets every 4-6 hours, as needed; not more than 12 tablets in 24 hours, or as directed by a doctor
  • children under 12 years: ask a doctor
Other Information (Other information)
  • each tablet contains: calcium 30 mg
  • store at 20-25°C (68-77°F); excursions permitted between 15°C - 30°C (59°F - 86°F)
  • protect from moisture • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
Inactive Ingredients (Inactive ingredients)

cellulose, D&C red #27 lake, dicalcium phosphate, magnesium stearate, PEG, polyvinyl alcohol, silica, starch, stearic acid, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-540-3765

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Diphenhydramine Hydrochloride 25mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)