tcr - 1090 - 2019-1016

tcr - 1090 - 2019-1016
SPL v5
SPL
SPL Set ID 53b15e75-9efd-4b4b-834b-6e9f12c60108
Route
oral
Published
Effective Date 2021-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (25 mg)
Inactive Ingredients
silicon dioxide croscarmellose sodium d&c red no. 27 calcium phosphate, dibasic, anhydrous fd&c yellow no. 6 hypromellose, unspecified magnesium stearate cellulose, microcrystalline polyethylene glycol, unspecified titanium dioxide aluminum oxide

Identifiers & Packaging

Pill Appearance
Imprint: 25;052 Shape: oval Color: pink Size: 11 mm Score: 1
Marketing Status
otc monograph drug active Since 2011-08-30 Until 2022-07-31
Purpose

Antihistamine

Description

Drug Facts

Medication Information

Active Ingredient

Diphenhydramine HCl 25 mg

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
Purpose

Antihistamine

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 and over 1 to 2 tablets
children 6 to under 12 years 1 tablet
children under 6 years do not use

Other Information
  • each tablet contains: calcium 45 mg
  • store between 20-25°C (68-77°F)
  • retain carton for complete product information
Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, dibasic calcium phosphate, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Description

Drug Facts

Principal Display Panel

NDC 36800-909-01

TopCare® Health™

Compare to Benadryl® Allergy Tablets Active Ingredient*

Allergy Relief

Diphenhydramine HCl 25 mg

Antihistamine

Relief of:

Sneezing

Itchy, watery eyes

Runny Nose

Itchy Throat

Pharmacists Recommend

24 Tablets

Section 42229-5

Drug Facts

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 50568-5

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

Section 50570-1

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Section 53414-9

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

When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Ask A Doctor Before Use If You Have
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Diphenhydramine HCl 25 mg

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
Purpose

Antihistamine

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 and over 1 to 2 tablets
children 6 to under 12 years 1 tablet
children under 6 years do not use

Other Information (Other information)
  • each tablet contains: calcium 45 mg
  • store between 20-25°C (68-77°F)
  • retain carton for complete product information
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, dibasic calcium phosphate, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 36800-909-01

TopCare® Health™

Compare to Benadryl® Allergy Tablets Active Ingredient*

Allergy Relief

Diphenhydramine HCl 25 mg

Antihistamine

Relief of:

Sneezing

Itchy, watery eyes

Runny Nose

Itchy Throat

Pharmacists Recommend

24 Tablets

Section 42229-5 (42229-5)

Drug Facts

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 50568-5 (50568-5)

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

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 53414-9 (53414-9)

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

When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:35.050321 · Updated: 2026-03-14T23:05:26.862879