160r Kroger 41226 160 Diphenhydramine Hydrochloride Tablets

160r Kroger 41226 160 Diphenhydramine Hydrochloride Tablets
SPL v4
SPL
SPL Set ID bc019c9e-8fac-5fd3-e053-2a95a90a7ccd
Route
ORAL
Published
Effective Date 2021-05-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: T;061 Shape: capsule Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-11
Description

Active ingredient (in each tablet) 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
  • itchy 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
  • do not take more than 6 doses in 24 hours

adults and children 12 years and over

1 to 2 tablets

children 6 to under 12 years

1 to 2 tablets

children under 6 years

1 to 2 tablets

Description

Active ingredient (in each tablet) 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 an enlarged prostate 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 dioxidede

Section 51945-4

Allergy 400ct Carton

Allergy 400ct Label

Allergy 100ct Carton

Allergy 100ct label

Allergy 24ct Carton

Section 53413-1

Questions or comments? Call 1-800-632-6900

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 tablet)

Diphenhydramine HCl 25 mg

Section 60561-8

Other information

  • each caplet contains: calcium 25 mg
  • protect from light
  • store at 25°C (77°F) excursions permitted 15°-30°C (59°-86°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
  • itchy 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
  • do not take more than 6 doses in 24 hours

adults and children 12 years and over

1 to 2 tablets

children 6 to under 12 years

1 to 2 tablets

children under 6 years

1 to 2 tablets

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 an enlarged prostate 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 dioxidede

Section 51945-4 (51945-4)

Allergy 400ct Carton

Allergy 400ct Label

Allergy 100ct Carton

Allergy 100ct label

Allergy 24ct Carton

Section 53413-1 (53413-1)

Questions or comments? Call 1-800-632-6900

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 tablet)

Diphenhydramine HCl 25 mg

Section 60561-8 (60561-8)

Other information

  • each caplet contains: calcium 25 mg
  • protect from light
  • store at 25°C (77°F) excursions permitted 15°-30°C (59°-86°F)
  • use by expiration date on package

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:23.522681 · Updated: 2026-03-14T23:09:09.169888