Histaprin

Histaprin
SPL v2
SPL
SPL Set ID 38786a65-a12b-4479-b63c-b7c15410da04
Route
ORAL
Published
Effective Date 2026-01-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Starch, Corn D&c Red No. 27 Aluminum Lake Dibasic Calcium Phosphate Dihydrate Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Silicon Dioxide Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;329 Shape: oval Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-01

Description

Active Ingredient (in each caplet) Diphenhydramine Hydrochloride 25mg


Medication Information

Warnings and Precautions

Warnings:

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

Indications and Usage

Uses:

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: 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. 1-800-222-1222

Section 50567-7

When using this 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 bronchitis
Section 51727-6

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Section 51945-4

Section 53414-9

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

Section 55105-1

Purpose:

Antihistamine

Section 55106-9

Active Ingredient (in each caplet)

Diphenhydramine Hydrochloride 25mg

Section 60561-8

Other information:

  • each caplet contains calcium 30mg
  • caplet enclosed in a sealed packet
  • do not use if packet is torn, cut, or open
  • store at 59° to 86°F (15°-30°C) in a dry place
  • avoid excessive heat and humidity
  • protect from light and moisture

Structured Label Content

Indications and Usage (34067-9)

Uses:

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: ask a doctor

Warnings and Precautions (34071-1)

Warnings:

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. 1-800-222-1222

Section 50567-7 (50567-7)

When using this 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 bronchitis
Section 51727-6 (51727-6)

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

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)

Purpose:

Antihistamine

Section 55106-9 (55106-9)

Active Ingredient (in each caplet)

Diphenhydramine Hydrochloride 25mg

Section 60561-8 (60561-8)

Other information:

  • each caplet contains calcium 30mg
  • caplet enclosed in a sealed packet
  • do not use if packet is torn, cut, or open
  • store at 59° to 86°F (15°-30°C) in a dry place
  • avoid excessive heat and humidity
  • protect from light and moisture

Advanced Ingredient Data


Raw Label Data

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