Valumeds Allergy Relief Antihistamine Diphenhydramine Hcl

SPL v2

SPL

SPL Set ID a5ceab90-6885-4f3a-b001-97679e03c01b

Route

ORAL

Published

Effective Date 2025-12-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Croscarmellose Sodium Dicalcium Phosphate D&c Red No. 27 Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol Titanium Dioxide Talc Silicon Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: S4 Shape: capsule Color: pink Size: 12 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-01-01

Description

Diphenhydramine HCl 25mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 25mg

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 of the cold:
runny nose
sneezing

Warnings

Directions

take every 4 to 6 hours or as directed by a doctor
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 tablet
children under 6 years	do not use

Drug Facts

Do Not Use

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

82725 1101 2

Other Information

protect from moisture
store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

Package Labeling:

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, d&c red 27, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, titanium dioxide, talc

Questions Or Comments?

contact 1-908-242-6108 Mon- Fri 8:00 AM EST to 5:00 PM PST

When Using This Product

drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness.
avoid alcoholic beverages
use caution 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 (1-800-222-1222) right away

Active Ingredient (in Each Tablet)

Diphenhydramine HCl 25mg

Ask A Doctor Before Use If You Have

trouble urinating due to an enlarged prostate gland
glaucoma

Ask Your Doctor Or Pharmacist Before Use If You Are

a breathing problem such as emphysema or chronic bronchitis
taking the blood thinning drug warfarin

Structured Label Content

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 of the cold:
runny nose
sneezing

Purpose

Antihistamine

Warnings

Directions

take every 4 to 6 hours or as directed by a doctor
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 tablet
children under 6 years	do not use

Drug Facts

Do Not Use (do not use)

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

82725 1101 2 (82725-1101-2)

Other Information (Other information)

protect from moisture
store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

Package Labeling:

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, d&c red 27, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, titanium dioxide, talc

Questions Or Comments? (Questions or Comments?)

contact 1-908-242-6108 Mon- Fri 8:00 AM EST to 5:00 PM PST

When Using This Product (When using this product)

drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness.
avoid alcoholic beverages
use caution 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 (1-800-222-1222) right away

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

Diphenhydramine HCl 25mg

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

trouble urinating due to an enlarged prostate gland
glaucoma

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

a breathing problem such as emphysema or chronic bronchitis
taking the blood thinning drug warfarin

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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 of the 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 doses 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", "do not use": "to make a child sleepy with any other product containing diphenhydramine, even one used on skin", "Other information": "protect from moisture store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)", "Inactive ingredients": "colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, d&c red 27, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, titanium dioxide, talc", "Questions or Comments?": "contact 1-908-242-6108 Mon- Fri 8:00 AM EST to 5:00 PM PST", "When using this product": "drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness. avoid alcoholic beverages use caution 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 (1-800-222-1222) right away", "Active ingredient (in each tablet)": "Diphenhydramine HCl 25mg", "Ask a doctor before use if you have": "trouble urinating due to an enlarged prostate gland glaucoma", "Ask your doctor or pharmacist before use if you are": "a breathing problem such as emphysema or chronic bronchitis taking the blood thinning drug warfarin"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:06.973988 · Updated: 2026-03-14T23:12:15.627416