Allergy Relief

Allergy Relief
SPL v5
SPL
SPL Set ID 32075381-97d9-4ea9-892f-2193ae058495
Route
ORAL
Published
Effective Date 2022-05-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: S4 Shape: oval Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-25
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

• itchy, watery eyes

• sneezing

• itching of the nose or throat

• temporarily relieves these symptoms due to the common cold:

• runny nose

• sneezing

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 50566-9

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Section 50567-7

When using this product • avoid alcoholic beverages

Section 50568-5

Ask a doctor or pharmacist before use if 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 • glaucoma

• difficulty in urination due to enlargement of the prostate gland

Section 50570-1

Do not use • for children under 12 years of age • 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.

Directions

• take only one dose per day (24 hours)

adults & children 12 years & over take 2 softgels at bedtime if needed or as directed by a doctor
children under 12 years do not use

Drug Facts

Other Information

• store at 20-25° C (68-77° F) • avoid excessive heat above 40° C (104° F) and high humidity • Protect from light

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C red # 27 aluminum lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions Or Comments?

1-888-333-9792

Principal Display Panel

Active Ingredient (in Each Tablet)

Diphenhydramine HCl 25 mg

Structured Label Content

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

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 50566-9 (50566-9)

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Section 50567-7 (50567-7)

When using this product • avoid alcoholic beverages

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if 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 • glaucoma

• difficulty in urination due to enlargement of the prostate gland

Section 50570-1 (50570-1)

Do not use • for children under 12 years of age • 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

Directions

• take only one dose per day (24 hours)

adults & children 12 years & over take 2 softgels at bedtime if needed or as directed by a doctor
children under 12 years do not use

Drug Facts

Other Information (Other information)

• store at 20-25° C (68-77° F) • avoid excessive heat above 40° C (104° F) and high humidity • Protect from light

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C red # 27 aluminum lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

Diphenhydramine HCl 25 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:57.137194 · Updated: 2026-03-14T23:06:08.994677