Histaprin

Histaprin
SPL v1
SPL
SPL Set ID 2cb8a04b-5c03-4e86-bf60-de9864fb483d
Route
ORAL
Published
Effective Date 2012-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Croscarmellose Sodium Lactose Magnesium Stearate Cellulose, Microcrystalline Silicon Dioxide Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: T061 Shape: oval Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2009-01-01
Description

Active Ingredient (in each caplet) Diphenhydramine Hydrochloride 25mg

Medication Information

Warnings and Precautions
Do not use with any other products containing diphenhydramine, even one used on skin

Indications and Usage

Temporarily relieves these symptoms due to the common cold, hay fever, or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
Dosage and Administration

Directions

Do not take more than directed

Adults and children 12 years of age and over:

  • Take 1 caplet every 4 to 6 hours while symptoms persist
  • do not take more than 6 caplets in 24 hours unless directed by a doctor
Children under 12 years of age: not intended for use in children under 12; ask a doctor

Description

Active Ingredient (in each caplet) Diphenhydramine Hydrochloride 25mg

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50567-7
When using the product

  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
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

  • trouble urinating due to enlarged prostate gland
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchiti
Section 51727-6

Enter section text here

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1
Antihistamine
Section 55106-9

Active Ingredient (in each caplet)

Diphenhydramine Hydrochloride 25mg

Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves these symptoms due to the common cold, hay fever, or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
Dosage and Administration (34068-7)

Directions

Do not take more than directed

Adults and children 12 years of age and over:

  • Take 1 caplet every 4 to 6 hours while symptoms persist
  • do not take more than 6 caplets in 24 hours unless directed by a doctor
Children under 12 years of age: not intended for use in children under 12; ask a doctor

Warnings and Precautions (34071-1)
Do not use with any other products containing diphenhydramine, even one used on skin

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.

Section 50567-7 (50567-7)
When using the product

  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • use caution 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 use if you are taking sedatives or tranquilizers

Section 50569-3 (50569-3)
Ask a doctor before use if you have

  • trouble urinating due to enlarged prostate gland
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchiti
Section 51727-6 (51727-6)

Enter section text here

Section 51945-4 (51945-4)

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 Ingredient (in each caplet)

Diphenhydramine Hydrochloride 25mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:29.760381 · Updated: 2026-03-14T22:53:14.066899