048 - Allergy Relief

048 - Allergy Relief
SPL v3
SPL
SPL Set ID bb709377-7bb3-4931-a2b6-2443aee07c12
Route
ORAL
Published
Effective Date 2024-01-26
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 Aluminum Lake Hypromellose, Unspecified Lactose, Unspecified Form Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Silicon Dioxide Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 048 Shape: capsule Color: pink Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-26

Description

Diphenhydramine HCl 25 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 25 mg

Use(s)

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

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

temporarily relieves these symptoms due to the common cold:

  • sneezing
  • runny nose
Directions

take every 4 to 6 hours, or as directed by a doctor

do not take more than 6 times 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 of age: do not use

Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Other Information

store at room temperature 20°– 25°C (68°– 77°F)

Questions/comments

Call 1-888-952-0050 (Monday-Friday 9AM-5PM EST)

Active Ingredient(s)

Diphenhydramine HCl 25 mg

Inactive Ingredients

croscarmellose sodium, D&C red #27 aluminum lake, hypromellose, lactose, magnesium

stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide



Principal Display Panel
Allergy Relief
When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Ask A Doctor Before Use If
  • a breathing problem such as emphysema or chronic bronchitis   
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
If Pregnant Or Breastfeeding,

ask a health professional before use

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 

Ask A Doctor Or Pharmacist Before Use If

are taking sedatives or tranquilizers


Structured Label Content

Use(s)

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

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

temporarily relieves these symptoms due to the common cold:

  • sneezing
  • runny nose
Purpose

Antihistamine

Directions

take every 4 to 6 hours, or as directed by a doctor

do not take more than 6 times 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 of age: do not use

Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Other Information (Other information)

store at room temperature 20°– 25°C (68°– 77°F)

Questions/comments (Questions/Comments)

Call 1-888-952-0050 (Monday-Friday 9AM-5PM EST)

Active Ingredient(s) (Active ingredient(s))

Diphenhydramine HCl 25 mg

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, D&C red #27 aluminum lake, hypromellose, lactose, magnesium

stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide



Principal Display Panel
Allergy Relief
When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Ask A Doctor Before Use If (Ask a doctor before use if)
  • a breathing problem such as emphysema or chronic bronchitis   
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use

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 (1-800-222-1222) right away. 

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

are taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)