allergy relief

allergy relief
SPL v9
SPL
SPL Set ID 5015a380-a229-4eff-8e31-528065c6ed64
Route
oral
Published
Effective Date 2024-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (25 mg)
Inactive Ingredients
croscarmellose sodium fd&c red no. 3 hypromelloses magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified talc dibasic calcium phosphate dihydrate titanium dioxide silicon dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 13 Shape: capsule Color: pink Size: 11 mm Score: 1
Marketing Status
otc monograph drug active Since 2024-01-23
Purpose

Antihistamine

Description

Drug Facts

Medication Information

Warnings

Active Ingredient

Diphenhydramine HCl 25 mg

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 25 mg
  • store between 20-25° C (68-77° F)
  • protect from moisture and light
Inactive Ingredients

dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, FD&C red #3, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide

Description

Drug Facts

Principal Display Panel

Allergy Relief

Diphenhydramine HCl 25 mg



Carton

Label

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 (1-800-222-1222) right away.

Section 50567-7

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
Section 50568-5

Ask a doctor or pharmacist before useif you are taking sedatives or tranquilizers

Section 50569-3

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
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.

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

Questions Or Comments?

1-800-373-6981

Structured Label Content

Warnings

Active Ingredient (Active ingredient (in each tablet))

Diphenhydramine HCl 25 mg

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 25 mg
  • store between 20-25° C (68-77° F)
  • protect from moisture and light
Inactive Ingredients (Inactive ingredients)

dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, FD&C red #3, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Allergy Relief

Diphenhydramine HCl 25 mg



Carton

Label

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 (1-800-222-1222) right away.

Section 50567-7 (50567-7)

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
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before useif you are taking sedatives or tranquilizers

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
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.

uses (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

Questions Or Comments? (Questions or comments?)

1-800-373-6981

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:44.673942 · Updated: 2026-03-14T23:11:08.891584