Allergy Relief

SPL v4

SPL

SPL Set ID 3d243264-5cd8-47da-9f5e-cfcfc8d1fa4b

Route

ORAL

Published

Effective Date 2025-12-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Phloxine Polyvinyl Alcohol Stearic Acid Talc Titanium Dioxide Dibasic Calcium Phosphate Dihydrate Silicon Dioxide Croscarmellose Sodium Fd&c Red No. 3 Hypromelloses

Identifiers & Packaging

Pill Appearance

Imprint: S4 Shape: capsule Color: pink Size: 11 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-12-04

Description

Drug Facts

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Drug Facts

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

Warnings

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

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C red no. 3, hypromellose, magnesium stearate, microcrystalline cellulose, phloxine B lake*, polyethylene glycol, polyvinyl alcohol, stearic acid*, talc, titanium dioxide

*may contain this ingredient

Questions Or Comments?

1-800-373-6981

Principal Display Panel

Allergy Relief

Diphenhydramine HCl 25 mg

Label

Active Ingredient (in Each Tablet)

Diphenhydramine HCl 25 mg

Structured Label Content

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.

Purpose

Antihistamine

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

Warnings

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)

*may contain this ingredient

Questions Or Comments? (Questions or comments?)

1-800-373-6981

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Allergy Relief

Diphenhydramine HCl 25 mg

Label

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

Diphenhydramine HCl 25 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"42229-5": "Drug Facts", "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.", "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", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers", "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", "50570-1": "Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Antihistamine", "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", "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": "colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C red no. 3, hypromellose, magnesium stearate, microcrystalline cellulose, phloxine B lake*, polyethylene glycol, polyvinyl alcohol, stearic acid*, talc, titanium dioxide *may contain this ingredient", "Questions or comments?": "1-800-373-6981", "PRINCIPAL DISPLAY PANEL": "Allergy Relief Diphenhydramine HCl 25 mg Label", "Active ingredient (in each tablet)": "Diphenhydramine HCl 25 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:33.312796 · Updated: 2026-03-14T23:11:08.891584