Cabinet Allergy Relief Refill, Diphenhydramine Hci

Cabinet Allergy Relief Refill, Diphenhydramine Hci
SPL v1
SPL
SPL Set ID d47553a4-ca15-4f0a-8177-d743a5c39cc5
Route
ORAL
Published
Effective Date 2025-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Dicalcium Phosphate D&c Red No. 27 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: S4 Shape: capsule Color: pink Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-12
Description

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

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

Warnings

Directions
  • take every 4 to 6 hours • do not take more than 6 doses in 24 hours
 adults & children 12 years & over 1 to 2 tablets
 children 6 to under 12 years 1 tablet
 children under 6 years  do not use this product in children under 6 years of age

Do Not Use

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

Drug Facts

Other Information

• each tablet contains:calcium 24 mg • store between 15–30°C (59–86°F) • protect from moisture and light

Package Labeling:

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Red No. 27 aluminum lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions Or Comments?

908-242-6108

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

If Pregnant Or Breast Feeding,

ask a health professional before use.

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)

Active Ingredient (in Each Tablet)

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

Structured Label Content

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

Warnings

Directions
  • take every 4 to 6 hours • do not take more than 6 doses in 24 hours
 adults & children 12 years & over 1 to 2 tablets
 children 6 to under 12 years 1 tablet
 children under 6 years  do not use this product in children under 6 years of age

Do Not Use (Do not use)

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

Drug Facts

Other Information (Other information)

• each tablet contains:calcium 24 mg • store between 15–30°C (59–86°F) • protect from moisture and light

Package Labeling:

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Red No. 27 aluminum lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

908-242-6108

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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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)

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

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:27.701351 · Updated: 2026-03-14T23:09:15.187219