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
Purpose

Antihistamine

Description

Diphenhydramine HCl 25 mg

Medication Information

Active Ingredient

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

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

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

Description

Diphenhydramine HCl 25 mg

Principal Display Panel

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.

Drug Facts

Questions Or Comments?

1-888-333-9792

Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

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

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

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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.

Drug Facts

Questions Or Comments? (Questions or comments?)

1-888-333-9792

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