OTC Medication Information: Diphenhydramine HCl 12.5mg Antihistamine

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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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 BitesNDC: 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
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
ANHYDROUS DEXTROSE
HYDROXYPROPYL BETADEX
MAGNESIUM STEARATE
MALTITOL
MALTODEXTRIN
MINERAL OIL
NEOTAME
WATER
CARRAGEENAN
SODIUM CHLORIDE
STARCH, CORN
CORN SYRUP
SUCRALOSE
SUCROSE
TRISODIUM CITRATE DIHYDRATE
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 Multilevel Packaging
1 NDC:50488-4125-1 20 BAR, CHEWABLE in 1 BOTTLE None
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)

Revised: 02/2021 Alexso, Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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