160r Walgreens 0363 0100 Diphenhydramine Hydrochloride 25 Mg Tablets

160r Walgreens 0363 0100 Diphenhydramine Hydrochloride 25 Mg Tablets
SPL v4
SPL
SPL Set ID c0270298-e7c5-e500-e053-2995a90aed23
Route
ORAL
Published
Effective Date 2025-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: T061 Shape: capsule Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-12-31

Description

Active ingredient (in each caplet) Diphenhydramine HCl 25 mg


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • Itching of the nose or throat

temporarily relieves these symptoms due to the common cold:

  • runny nose
  • sneezing
Dosage and Administration

Directions

  • Take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours

adults and children 12 years of age and over: 1 to 2 caplets

children 6 to under 12 years of age: 1 caplet

children under 6 years of age: do not use

Description

Active ingredient (in each caplet) Diphenhydramine HCl 25 mg

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50567-7

When using this product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery
Section 50568-5

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

Section 50569-3

Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to enlarged prostrate gland
  • a breathing problem such as emphysema or chronic bronchitis
Section 50570-1

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Section 51727-6

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, titanium dioxide

Section 51945-4

Section 53414-9

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

Section 55105-1

Purpose

Antihistamine

Section 55106-9

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Section 60561-8

Other information

  • each caplet contains: calcium 25 mg
  • protect from light
  • Store between 20-25°C (68-77° F)
  • use by expiration date on package

Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • Itching of the nose or throat

temporarily relieves these symptoms due to the common cold:

  • runny nose
  • sneezing
Dosage and Administration (34068-7)

Directions

  • Take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours

adults and children 12 years of age and over: 1 to 2 caplets

children 6 to under 12 years of age: 1 caplet

children under 6 years of age: do not use

Warnings and Precautions (34071-1)

Warnings

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. (1-800-222-1222)

Section 50567-7 (50567-7)

When using this product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery
Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to enlarged prostrate gland
  • a breathing problem such as emphysema or chronic bronchitis
Section 50570-1 (50570-1)

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Section 51727-6 (51727-6)

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, titanium dioxide

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Antihistamine

Section 55106-9 (55106-9)

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Section 60561-8 (60561-8)

Other information

  • each caplet contains: calcium 25 mg
  • protect from light
  • Store between 20-25°C (68-77° F)
  • use by expiration date on package

Advanced Ingredient Data


Raw Label Data

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