DIPHENHYDRAMINE HCL 12.5MG ANTIHISTAMINE- diphenhydramine hydrochloride bar, chewable 
Alexso, Inc

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Diphenhydramine HCl Soft Chew

Diphenhydramine HCl 12.5 mg Soft Chews

Alexso, Inc.

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Diphenhydramine HCl 12.5 mg Soft Chews

DRUG FACTS

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

WARNINGS

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 Chews
20 Bubble Gum Flavored Gummies
Chewy Gummy Bites
NDC:50488-4125-1     Patent Pending

DIPHENHYDRAMINE HCL 12.5MG ANTIHISTAMINE 
diphenhydramine hydrochloride bar, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50488-4125
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTITOL (UNII: D65DG142WK)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MINERAL OIL (UNII: T5L8T28FGP)  
NEOTAME (UNII: VJ597D52EX)  
WATER (UNII: 059QF0KO0R)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
STARCH, CORN (UNII: O8232NY3SJ)  
CORN SYRUP (UNII: 9G5L16BK6N)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
Product Characteristics
Coloryellow (Light yellow to golden brown) Scoreno score
ShapeRECTANGLESize18mm
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50488-4125-120 in 1 BOTTLE; Type 0: Not a Combination Product02/08/202103/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01202/08/202103/31/2023
Labeler - Alexso, Inc (963338061)

Revised: 11/2024
 
Alexso, Inc