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

Purpose

Antihistamine

Description

Diphenhydramine HCl 25 mg


Medication Information

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

Other Information

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

Inactive Ingredients

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

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



Description

Diphenhydramine HCl 25 mg

Principal Display Panel
Allergy Relief
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
Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Questions/comments

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

Active Ingredient(s)

Diphenhydramine HCl 25 mg

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

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

Other Information (Other information)

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

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
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
Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Questions/comments (Questions/Comments)

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

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

Diphenhydramine HCl 25 mg

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)