Gc 681 (683)

Gc 681 (683)
SPL v4
SPL
SPL Set ID 7fc05877-6ce8-4b2e-afba-9e043150e1c5
Route
ORAL
Published
Effective Date 2025-01-13
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 Silicon Dioxide D&c Red No. 27 Microcrystalline Cellulose Anhydrous Dibasic Calcium Phosphate 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 2021-10-21

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.

Warnings

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, including 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 are

  • taking sedatives or tranquilizers

When using this product

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

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: consult a doctor
Package Label
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.

Repackaged By: Preferred Pharmaceuticals Inc.

Inactive Ingredients

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

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.

Purpose

Antihistamine

Warnings

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, including 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 are

  • taking sedatives or tranquilizers

When using this product

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

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: consult a doctor
Package Label (package label)
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.

Repackaged By: Preferred Pharmaceuticals Inc.

Inactive Ingredients (Inactive ingredients)

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

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

Diphenhydramine Hydrochloride 25mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)