Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ba0ecb7f-9389-44af-98ed-a2c41c793ef8
Route
ORAL
Published
Effective Date 2012-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Titanium Dioxide Polysorbate 80 Carnauba Wax Polyethylene Glycol 300 Cellulose, Microcrystalline Magnesium Stearate Croscarmellose Sodium Silicon Dioxide Lactose D&c Red No. 27

Identifiers & Packaging

Pill Appearance
Imprint: T;061 Shape: capsule Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-10-15
Description

Active Ingredients Diphenhydramine HCl 25 mg

Medication Information

Warnings and Precautions
Warnings: Do not use • to make a child sleepy

• with any other product containing diphenhydramine, even one

used on skin 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 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.
Indications and Usage

Uses: • temporarily relieves these symptoms due to hay fever

or other upper respiratory allergies: • runny nose • sneezing

• itchy, watery eyes • itchy nose or throat • temporarily relieves

these symptoms due to the common cold: • runny nose

• sneezing

Dosage and Administration

Directions • take every 4 to 6 hours • do

not take more than 6 doses in 24 hours Adults

and children 12 years of age and over: 1 to 2

caplets • Children 6 to under 12 years of age: 1

caplet • children under 6 years of age: do not use

this product in children under 6 years of age

Description

Active Ingredients Diphenhydramine HCl 25 mg

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Section 51727-6

Inactive ingredients: carnauba wax,

colloidal silicon dioxide, croscarmellose sodium, DC red 27

aluminum lake, dibasic calcium phosphate dihydrate,

hydroxypropylmethyl cellulose, hypromellose, lactose,

magnesium stearate, microcrystalline cellulose, polyethylene

glycol (PEG) 400, polysorbate 80, silicon dioxide, titanium

dioxide

Section 51945-4

MM1

Section 53414-9

If pregnant or

breast-feeding, ask a health professional before use.

Section 55105-1

Antihistamine

Section 55106-9

Active Ingredients

Diphenhydramine HCl 25 mg

Structured Label Content

Indications and Usage (34067-9)

Uses: • temporarily relieves these symptoms due to hay fever

or other upper respiratory allergies: • runny nose • sneezing

• itchy, watery eyes • itchy nose or throat • temporarily relieves

these symptoms due to the common cold: • runny nose

• sneezing

Dosage and Administration (34068-7)

Directions • take every 4 to 6 hours • do

not take more than 6 doses in 24 hours Adults

and children 12 years of age and over: 1 to 2

caplets • Children 6 to under 12 years of age: 1

caplet • children under 6 years of age: do not use

this product in children under 6 years of age

Warnings and Precautions (34071-1)
Warnings: Do not use • to make a child sleepy

• with any other product containing diphenhydramine, even one

used on skin 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 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 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Section 51727-6 (51727-6)

Inactive ingredients: carnauba wax,

colloidal silicon dioxide, croscarmellose sodium, DC red 27

aluminum lake, dibasic calcium phosphate dihydrate,

hydroxypropylmethyl cellulose, hypromellose, lactose,

magnesium stearate, microcrystalline cellulose, polyethylene

glycol (PEG) 400, polysorbate 80, silicon dioxide, titanium

dioxide

Section 51945-4 (51945-4)

MM1

Section 53414-9 (53414-9)

If pregnant or

breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Antihistamine

Section 55106-9 (55106-9)

Active Ingredients

Diphenhydramine HCl 25 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:32.580248 · Updated: 2026-03-14T22:53:18.854428