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NDC 50488-4125-01 Diphenhydramine HCl 12.5mg Antihistamine 12.5 mg/1 Details

Diphenhydramine HCl 12.5mg Antihistamine 12.5 mg/1

Diphenhydramine HCl 12.5mg Antihistamine is a ORAL BAR, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Alexso, Inc. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 50488-4125-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	50488-4125
Product ID	50488-4125_0fd04f20-1efc-4fb5-ab7a-8d930dd989e4
Associated GPIs	41200030100510
GCN Sequence Number	023635
GCN Sequence Number Description	diphenhydramine HCl TAB CHEW 12.5 MG ORAL
HIC3	Z2P
HIC3 Description	ANTIHISTAMINES - 1ST GENERATION
GCN	46060
HICL Sequence Number	004480
HICL Sequence Number Description	DIPHENHYDRAMINE HCL
Brand/Generic	Generic
Proprietary Name	Diphenhydramine HCl 12.5mg Antihistamine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Diphenhydramine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	BAR, CHEWABLE
Route	ORAL
Active Ingredient Strength	12.5
Active Ingredient Units	mg/1
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE
Labeler Name	Alexso, Inc
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 50488-4125-01 (50488412501)

Pricing Information	N/A
NDC Package Code	50488-4125-1
Billing NDC	50488412501
Package	20 BAR, CHEWABLE in 1 BOTTLE (50488-4125-1)
Marketing Start Date	2021-02-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 41b6e96a-9fce-4aa2-9eeb-3a5bd5f7af41 Details

SPL UNCLASSIFIED SECTION

Diphenhydramine HCl 12.5 mg Soft Chews

Alexso, Inc.

----------------

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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Labeler - Alexso, Inc (963338061)

Revised: 2/2021

Document Id: 0fd04f20-1efc-4fb5-ab7a-8d930dd989e4

Set id: 41b6e96a-9fce-4aa2-9eeb-3a5bd5f7af41

Version: 2

Effective Time: 20210224