FDA Label for Diphenhydramine Hcl 12.5mg Antihistamine

Active Ingredient (In Each Soft Chew)

Diphenhydramine HCl 12.5mg

Purpose

Antihistamine

Uses

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

• Runny nose
  
• Itchy, watery eyes
  
• Sneezing
  
• Itching of the nose or throat

Do Not Use

• To make 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

• Excitability may occur, especially in children
  
• Marked drowsiness may occur
  
• Avoid alcoholic drinks
  
• 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 Reach Of Children.

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

Directions

Adults and children 12 years and over:

• Take 2 to 4 soft chews (25 mg to 50 mg) every 4 to 6 hours, or as directed by a doctor
  
• Do not take more than 6 times in 24 hours
  
• Chew each soft chew thoroughly before swallowing

Children 6 to 11 years:

• Take 1 to 2 soft chews (12.5 mg to 25 mg) every 4 to 6 hours, or as directed by a doctor.
  
• Do not take more than 6 times in 24 hours
  
• Chew each soft chew thoroughly before swallowing

Children under 6 years: Do not use

Other Information

• each soft chew contains: sodium 7 mg. Very low sodium.
  
• store in a cool dry place between 20-25°C (68-77°F).
  
• Child Resistant Container; do not use if printed seal under cap is broken or missing.

Inactive Ingredients:

citric acid, flavor, glucose syrup, hydroxypropyl betadex, magnesium stearate, maltitol solution, maltodextrin, mineral oil, neotame, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate.

Questions Or Comments?

Call 888-495-6078

How Supplied

Diphenhydramine 12.5mg Soft Chews is supplied in the following dosage form:

Twenty (20) Soft Chews per container

***Made in USA***

Manufactured for:
Alexso, Inc.
2317 Cotner Ave
Los Angeles, CA 90064

NDC: 50488-4125-1
Size: 20 Soft Chews

Principal Display Panel

Diphenhydramine HCl 12.5 mg Soft Chews
20 Bubble Gum Flavored Gummies

Chewy Gummy Bites
NDC: 50488-4125-1 Patent Pending

Diphenhydramine HCl 12.5 mg Soft Chews20 Bubble Gum Flavored GummiesChewy Gummy BitesNDC:50488-4125-1 Patent Pending - diphenhydramine hcl soft chew 01