DIPHENHYDRAMINE HCL 12.5MG ANTIHISTAMINE- diphenhydramine hydrochloride bar, chewable

Diphenhydramine HCl 12.5mg Antihistamine by

Drug Labeling and Warnings

Diphenhydramine HCl 12.5mg Antihistamine by is a Otc medication manufactured, distributed, or labeled by Alexso, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL 12.5MG ANTIHISTAMINE 
diphenhydramine hydrochloride bar, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50488-4125
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	YELLOW (Light yellow to golden brown)	Score	no score
Shape	RECTANGLE	Size	18mm
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50488-4125-1	20 in 1 BOTTLE; Type 0: Not a Combination Product	02/08/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	02/08/2021

Labeler - Alexso, Inc (963338061)