Active Ingredient (In Each 5 Ml)
Diphenhydramine HCl 12.5mg
Diphenhydramine Hydrochloride
FDA Label NDC 81033-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kesin Pharma Corporation for the product Diphenhydramine Hydrochloride (NDC 81033-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each 5 ml), purpose, uses, do not use, ask a doctor before use if your child has, ask a doctor or pharmacist before use if the child is, when using this product, keep our of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Uses
For the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies or allergic rhinitis.
Do Not Use
• to make a child sleepy
• with any other product containing diphenhydramine, even one used on skin
• this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland
Ask A Doctor Before Use If Your Child Has
• a breathing problem such as chronic bronchitis
• glaucoma
• a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If The Child Is
• taking sedatives or tranquilizers
When Using This Product
• marked drowsiness may occur
• sedatives and tranquilizers may increase drowsiness
• excitability may occur, especially in children
• avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.
Keep Our Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
Adults and children 12 years of age and over: oral dosage is 25 to 50 milligrams every 4 to 6 hours, not to exceed 300 milligrams in 24 hours, or as directed by a doctor.
Children 6 to under 12 years of age: oral dosage is 12.5 to 25 milligrams every 4 to 6 hours, not to exceed 150 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.
Other Information
• each 5 mL contains: 16mg of sodium
• store at 20°-25°C (68°-77°F)
• tamper evident: DO NOT use if foil on cup is missing or torn
• Alcohol Free, Dye Free, Sugar Free
• NDC 81033-003-05 (12.5mg) unit dose cup
• NDC 81033-003-10 (25 mg) unit dose cup
Inactive Ingredients
citric acid, glycerin, propylene glycol, water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum, mixed berry flavor, strawberry flavor
Questions Or Comments?
Call 1-833-537-4679
How Supplied
• NDC 81033-003-05 (12.5mg) unit dose cup
• NDC 81033-003-10 (25 mg) unit dose cup
Principal Display Panel
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NDC 81033-003-05
Diphenhydramine
HCl Oral Solution
Delivers 12.5mg / 5 mL
12.5mg / 5 mL
Store at 68° - 77° F
[ Lot # Exp Date]
PKG by Kesin Pharma
Phoenix, AZ
Sugar, Alcohol, Dye Free
For Institutional Use Only
[Barcode]
[Barcode]
NDC 81033-003-10
Diphenhydramine
HCl Oral Solution
Delivers 25mg / 10 mL
12.5mg / 5 mL
Store at 68° - 77° F
[Lot #] PKG by
[Exp Date] Kesin Pharma
Phoenix, AZ
Sugar, Alcohol, Dye Free
For Institutional Use Only
[Barcode]
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