Diphenhydramine Hcl 25 Mg Caplets

Diphenhydramine Hcl 25 Mg Caplets
SPL v7
SPL
SPL Set ID 32f58cb3-941f-263b-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2015-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Croscarmellose Sodium D&c Red No. 27 Cellulose, Microcrystalline Hypromelloses Magnesium Stearate Dibasic Calcium Phosphate Dihydrate Polyethylene Glycol 1000 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: AP;135 Shape: oval Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-11-01

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy nose or throat
  • itchy, watery eyes
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50567-7

When using this product

  • you may get very drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives, & tranquilizers may increase drowsiness
  • be careful 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

Drug Facts continued on back of label

Section 50569-3

Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breating problem such as emphysema or chronic bronchitis
Section 51945-4

NDC 69618-025-01

Diphenhydramine HCL 25 mg

ANTIHISTAMINE

100 CAPLETS

*Compare to Active Ingredient in BENADRYL® ALLERGY

Section 53414-9

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

Warnings

Do not use

  • with any other product containing diphenhydramine, even one use on skin
  • to make a child sleepy
Directions
  • take every 4-6 hours
  • do not take more than 6 doses in 24 hours
adults and children 12 years and over 1 to 2 caplets
children 6 to under 12 years 1 caplet
children under 6 years do not use

Other Information
  • each caplet contains: calcium 45 mg
  • store at room temperature
  • protect from moisture
Inactive Ingredients

croscarmellose sodium, D&C red #27, dicalcium phosphate, HPMC, magnesium stearate, microcrystalline cellulose, PEG, titanium dioxide

Questions Or Comments?

call 516-341-0666, 8:30 am - 4:30 pmET, Monday - Friday

Active Ingredient (in Each Caplet)

Diphenhydramine HCL 25 mg


Structured Label Content

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy nose or throat
  • itchy, watery eyes
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

When using this product

  • you may get very drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives, & tranquilizers may increase drowsiness
  • be careful 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

Drug Facts continued on back of label

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breating problem such as emphysema or chronic bronchitis
Section 51945-4 (51945-4)

NDC 69618-025-01

Diphenhydramine HCL 25 mg

ANTIHISTAMINE

100 CAPLETS

*Compare to Active Ingredient in BENADRYL® ALLERGY

Section 53414-9 (53414-9)

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

Purpose

Antihistamine

Warnings

Do not use

  • with any other product containing diphenhydramine, even one use on skin
  • to make a child sleepy
Directions
  • take every 4-6 hours
  • do not take more than 6 doses in 24 hours
adults and children 12 years and over 1 to 2 caplets
children 6 to under 12 years 1 caplet
children under 6 years do not use

Other Information (Other information)
  • each caplet contains: calcium 45 mg
  • store at room temperature
  • protect from moisture
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, D&C red #27, dicalcium phosphate, HPMC, magnesium stearate, microcrystalline cellulose, PEG, titanium dioxide

Questions Or Comments? (Questions or comments?)

call 516-341-0666, 8:30 am - 4:30 pmET, Monday - Friday

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Diphenhydramine HCL 25 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)