Diphenhydramine 25mg

Diphenhydramine 25mg
SPL v1
SPL
SPL Set ID a2f31f98-b89a-8e66-e053-2995a90a70ac
Route
ORAL
Published
Effective Date 2020-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Carnauba Wax Silicon Dioxide Croscarmellose Sodium D&c Red No. 27 Hypromelloses Cellulose, Microcrystalline Calcium Phosphate, Dibasic, Dihydrate Magnesium Stearate Polyethylene Glycol 400 Polysorbate 80 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: T;061 Shape: capsule Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-09-01

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.

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

New! Ultra Small Tablets

NDC 57896-681-01

GERICARE

GERI-DRYL

(ALLERGY RELIEF)

Diphenhydramine HCl

Antihistamine

Compare to active ingredient in Benadryl Ultratabs

PACKAGE NOT CHILD RESISTANT

100 Tablets

25 mg each

Other Information
  • each tablet contains: calcium 25mg

  • store at room temperature 15⁰C - 30⁰C (59⁰F - 86⁰F)
  • for institutional use only
Inactive Ingredients

cellulose, croscarmellose sodium, D&C red #27 lake, dicalcium phosphate, hypromellose, magnesium stearate, PEG, polysorbate 80, silica, titanium dioxide, wax.

Active Ingredient (in Each Tablet)

Diphenhydramine Hydrochloride 25mg

Package Label.principal Display Panel


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)

New! Ultra Small Tablets

NDC 57896-681-01

GERICARE

GERI-DRYL

(ALLERGY RELIEF)

Diphenhydramine HCl

Antihistamine

Compare to active ingredient in Benadryl Ultratabs

PACKAGE NOT CHILD RESISTANT

100 Tablets

25 mg each

Other Information (Other information)
  • each tablet contains: calcium 25mg

  • store at room temperature 15⁰C - 30⁰C (59⁰F - 86⁰F)
  • for institutional use only
Inactive Ingredients (Inactive ingredients)

cellulose, croscarmellose sodium, D&C red #27 lake, dicalcium phosphate, hypromellose, magnesium stearate, PEG, polysorbate 80, silica, titanium dioxide, wax.

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

Diphenhydramine Hydrochloride 25mg

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)