Allergy

Allergy
SPL v3
SPL
SPL Set ID a1e4781a-6715-461a-9289-94da68129f4a
Route
ORAL
Published
Effective Date 2019-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Silicon Dioxide D&c Red No. 27 Anhydrous Dibasic Calcium Phosphate Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol 400 Stearic Acid Titanium Dioxide Starch, Corn Polyvinyl Alcohol, Unspecified Talc

Identifiers & Packaging

Pill Appearance
Imprint: PH25 Shape: oval Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-03-13

Description

(in each caplet) Diphenhydramine HCl (25 mg)


Medication Information

Description

(in each caplet) Diphenhydramine HCl (25 mg)

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

  • sneezing
  • nasal congestion
  • runny nose
  • itchy, watery eyes

Temporarily relieves these symptoms due to common cold

  • runny nose
  • sneezing
Section 51945-4

ALLERGY

Diphenhydramine HCI 25mg | Antihistamine

Runny Nose Nasal Congestion

Sneezing Itchy Watery Eyes

COMPARE TO THE ACTIVE INGREDIENTS IN

BENADRYL® *

6 TABLETS

Section 55105-1

Antihistamine

Warnings

Do not use

  • to make a child sleepy
  • with any other product containing Diphenhydramine, even one used on the skin
Directions
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours

adults and children 12 years and over         1 to 2 tablets

children 6 to under 12 years                       1 tablet

children under 6 years                               ask a doctor

Active Ingredient

(in each caplet)

Diphenhydramine HCl (25 mg)

Inactive Ingredients

colloidal silicon dioxide, corn starch, D & C red # 27 Aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide

Questions Or Comments?

Call 1-844-428-2538

When Using This Product
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • excitability may occur, especially in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
If Pregnant Or Breast Feeding

ask a health professional before use

Keep Out of the Reach of Children

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

Ask A Doctor Before Use If You Have
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizers

Structured Label Content

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

  • sneezing
  • nasal congestion
  • runny nose
  • itchy, watery eyes

Temporarily relieves these symptoms due to common cold

  • runny nose
  • sneezing
Section 51945-4 (51945-4)

ALLERGY

Diphenhydramine HCI 25mg | Antihistamine

Runny Nose Nasal Congestion

Sneezing Itchy Watery Eyes

COMPARE TO THE ACTIVE INGREDIENTS IN

BENADRYL® *

6 TABLETS

Section 55105-1 (55105-1)

Antihistamine

Warnings

Do not use

  • to make a child sleepy
  • with any other product containing Diphenhydramine, even one used on the skin
Directions
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours

adults and children 12 years and over         1 to 2 tablets

children 6 to under 12 years                       1 tablet

children under 6 years                               ask a doctor

Active Ingredient (Active ingredient)

(in each caplet)

Diphenhydramine HCl (25 mg)

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, corn starch, D & C red # 27 Aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call 1-844-428-2538

When Using This Product (When using this product)
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • excitability may occur, especially in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use

Keep Out of the Reach of Children (Keep out of the reach of children)

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)