Diphenhydramine Hcl 25mg, Usp

Diphenhydramine Hcl 25mg, Usp
SPL v1
SPL
SPL Set ID 046f3426-802d-491b-9c12-4ee711898f6b
Route
ORAL
Published
Effective Date 2016-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Carnauba Wax Silicon Dioxide Croscarmellose Sodium D&c Red No. 27 Dibasic Calcium Phosphate Dihydrate Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycols Polysorbate 80 Titanium Dioxide Polyvinyl Alcohol Povidone Starch, Corn Sodium Benzoate Talc

Identifiers & Packaging

Pill Appearance
Imprint: EL Shape: capsule Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-11-25

Description

(in each tablet) Diphenhydramine HCl 25 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

(in each tablet) Diphenhydramine HCl 25 mg

Uses

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

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

    temporarily relieves these symptoms due to the common cold:

  • runny nose
  • sneezing
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

  • 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

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

Directions
  • take every 4 to 6 hours
  • do not take more than 6 tablets in 24 hours
    Age (Yr) Dose (tablets)
    Adults and children 12 years of age and over Take 1 to 2 tablets
    Children 6 to under 12 years of age Take 1 tablet
    Children under 6 years of age do not use
Active Ingredient

(in each tablet)

Diphenhydramine HCl 25 mg

Other Information
  • store at 25°C(77 °F) excusrsions permitted between 15°-30°C (59°-86°F)
  • protect from light and moisture
  • metal content: each tablet contains: Calcium 23mg, Magnesium: 0.2 mg, sodium 0.5 mg
Inactive Ingredients

Carnauba Wax, Colloidal silion dioxide, croscarmellose sodium, D&C red #27 al lake, dibasic calcium phosphate dihydrate, hypromellose, Lecithin,  magnesium stearate, microcrystalline cellulose, polyethylene glycol, Polyvinyl Alcohol, polysorbate, Povidone, Purified water, starch, sodium benozoate, talc,Titanium Dioxide

Questions Or Comments

Call 1-855-314-1850

READ AND KEEP CARTON FOR COMPLETE WARNING AND INFORMATION

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)

Package Label.principal Display Panel

NDC 70677-0009-1


Structured Label Content

Uses

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

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

    temporarily relieves these symptoms due to the common cold:

  • runny nose
  • sneezing
Purpose

Antihistamine

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

  • 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

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

Directions
  • take every 4 to 6 hours
  • do not take more than 6 tablets in 24 hours
    Age (Yr) Dose (tablets)
    Adults and children 12 years of age and over Take 1 to 2 tablets
    Children 6 to under 12 years of age Take 1 tablet
    Children under 6 years of age do not use
Active Ingredient

(in each tablet)

Diphenhydramine HCl 25 mg

Other Information
  • store at 25°C(77 °F) excusrsions permitted between 15°-30°C (59°-86°F)
  • protect from light and moisture
  • metal content: each tablet contains: Calcium 23mg, Magnesium: 0.2 mg, sodium 0.5 mg
Inactive Ingredients

Carnauba Wax, Colloidal silion dioxide, croscarmellose sodium, D&C red #27 al lake, dibasic calcium phosphate dihydrate, hypromellose, Lecithin,  magnesium stearate, microcrystalline cellulose, polyethylene glycol, Polyvinyl Alcohol, polysorbate, Povidone, Purified water, starch, sodium benozoate, talc,Titanium Dioxide

Questions Or Comments (Questions or Comments)

Call 1-855-314-1850

READ AND KEEP CARTON FOR COMPLETE WARNING AND INFORMATION

Keep Out of Reach of Children. (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)

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 70677-0009-1


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)