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Animal NDC 72087-021-10 Calmatrol

Diphenhydramine

Animal Product Information

Field Name Field Value
Animal NDC Code 72087-021-10
Proprietary Name Calmatrol What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Diphenhydramine What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Goldman Pharmaceutical Group Inc
Product Type Otc Animal Drug
Active Ingredient(s)
  • Diphenhydramine Hydrochloride
Inactive Ingredient(s)
  • BUTYLPARABEN (3QPI1U3FV8)
  • GELATIN, UNSPECIFIED (2G86QN327L)
  • MAGNESIUM STEARATE (70097M6I30)
  • PROPYLPARABEN (Z8IX2SC1OH)
  • POLYSORBATE 80 (6OZP39ZG8H)
  • STARCH, CORN (O8232NY3SJ)
  • METHYLPARABEN (A2I8C7HI9T)
  • BUTYLPARABEN (3QPI1U3FV8)
  • GELATIN, UNSPECIFIED (2G86QN327L)
  • MAGNESIUM STEARATE (70097M6I30)
  • PROPYLPARABEN (Z8IX2SC1OH)
  • POLYSORBATE 80 (6OZP39ZG8H)
  • STARCH, CORN (O8232NY3SJ)
  • METHYLPARABEN (A2I8C7HI9T)
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Calmatrol Images

Calmatrol Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Drug Facts

Active ingredient (in each capsule)Purpose
Diphenhydramine HCl 25 mgAntihistamine

Uses

  • for the relief of occasional restlessness, hyperactivity and destructive behavior
  • for the relief of anxiety associated with noise, change of environment, loneliness and stress

    • Inactive Ingredients

    D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose and starch


Warnings



Warnings

Do not use with any other product containing diphenhydramine

  • ask a veterinarian before use if your dog has any chronic illnesses
  • ask a veterinarian or pharmacist if your dog is on any other medication before use
  • keep out of reach of children in case of overdose contact poison control center immediately
  • stop use and contact veterinarian if symptoms persist for more than 72 hours
  • do not use on dogs under 12 pounds

Dosage & Administration



Directions

  • give one capsule every 8 hours as needed
  • for dogs between 12 to 25 pounds
  • do not give more than 3 doses within any 24 hour period

Storage And Handling



Other information

  • store at room temperature 20 - 25 C (66 - 78 F)
  • protect from moisture
  • see end flap for expiration date and lot #

Principal Display Panel - 25 Mg Capsule Blister Pack Carton



pet
otc™
over the counter

Calmatrol®
(Diphenhydramine HCl, 25mg) Antihistamine

HELPS TO
RELIEVE:
Anxiety
Hyperactivity
Destructive behavior

12 - 25 lbs

10 CAPSULES

MADE IN THE USA

Highly recommended by
veterinarians

NDC 72087-021-10


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.