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

Warnings

Do not use

  • to make a child sleepy
  • with any other product containing Diphenhydramine, even one used on the skin
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
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

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

Description

(in each caplet) Diphenhydramine HCl (25 mg)

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

Active Ingredient

(in each caplet)

Diphenhydramine HCl (25 mg)

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

Warnings

Do not use

  • to make a child sleepy
  • with any other product containing Diphenhydramine, even one used on the skin
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
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

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

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

Active Ingredient (Active ingredient)

(in each caplet)

Diphenhydramine HCl (25 mg)

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)