Active Ingredient (In Each Teaspoon (5 Ml))
Diphenhydramine HCl USP 12.5 mg
Diphenhydramine Hydrochloride
FDA Label NDC 54868-1227
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Diphenhydramine Hydrochloride (NDC 54868-1227). 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 teaspoon (5 ml)), purpose, uses, do not use, ask a doctor before use if you have, when using this product, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
Do Not Use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Ask A Doctor Before Use If You Have
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
When Using This Product
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Directions
- take every 4 to 6 hours
- do not take more than 6 doses in 24 hours
| adults and children 12 years and over | 2 to 4 teaspoons (25 mg to 50 mg) |
| children 6 to under 12 years | ask a doctor |
| children 4 to 5 years | do not use unless directed by a doctor |
| children under 4 years | do not use |
Other Information
- each teaspoon (5 mL) contains: sodium 5 mg
- store between 20°-25°C (68°-77°F). Protect from light.
Inactive Ingredients
artificial cherry flavors, citric acid, D&C Red #33, FD&C Red #40, glycerin, polysorbate 20, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution
Questions?
call 1-888-838-2872, weekdays, 8 AM - 5 PM Eastern Time
Principal Display Panel
NDC 54868-1227-0
Image Of Package Label (1227)
TAMPER-EVIDENT
Diphenhydramine HCl USP
12.5 mg per 5 mL)
ONE PINT (473 mL)
ANTIHISTAMINE
ALCOHOL-FREE
SUGAR-FREE
CHERRY-FLAVORED
TAMPER-EVIDENT: Do not use this product if
inner foil seal over the mouth of the bottle
is cut, torn, broken or missing.
NOT FOR HOUSEHOLDS
WITH YOUNG CHILDREN
* Please review the disclaimer below.
