Label: CALMATROL- diphenhydramine capsule
- NDC Code(s): 72087-022-20
- Packager: Goldman Pharmaceutical Group Inc
- This is a repackaged label.
- Source NDC Code(s): 0904-2035
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated February 20, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- INDICATIONS & USAGE
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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 26 pounds
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 25 mg Capsule Blister Pack Carton
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INGREDIENTS AND APPEARANCE
CALMATROL
diphenhydramine capsuleProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:72087-022(NDC:0904-2035) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength BUTYLPARABEN (UNII: 3QPI1U3FV8) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) MAGNESIUM STEARATE (UNII: 70097M6I30) PROPYLPARABEN (UNII: Z8IX2SC1OH) POLYSORBATE 80 (UNII: 6OZP39ZG8H) STARCH, CORN (UNII: O8232NY3SJ) METHYLPARABEN (UNII: A2I8C7HI9T) Product Characteristics Color PINK (pink) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code 44;107 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72087-022-20 20 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 03/01/2019 Labeler - Goldman Pharmaceutical Group Inc (080389804) Registrant - Goldman Pharmaceutical Group, Inc. (080389804) Establishment Name Address ID/FEI Business Operations Goldman Pharmaceutical Group, Inc. 080389804 REPACK
