FDA Label for Diphenhydramine Hcl
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TEASPOONFUL (5 ML))
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Diphenhydramine Hcl Product Label
The following document was submitted to the FDA by the labeler of this product Atlantic Biologicals Corp.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Teaspoonful (5 Ml))
Diphenhydramine HCl 12.5 mg
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
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- excitability may occur, especially in children
- marked drowsiness may occur
- use caution 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 right away.
Directions
- do not take more than 6 doses in 24 hours
- mL = milliliter; FL OZ = fluid ounce
- find right dose on chart below
- take every 4 to 6 hours, or as directed by a doctor
| Age | Dose |
| adults and children 12 years and over | 2 - 4 teaspoonsful (25 mg to 50 mg) |
| children 6 to 11 years | 1 - 2 teaspoonsful (12.5 mg to 25 mg) |
| children 2 to 5 years | do not use unless directed by a doctor |
| children under 2 years | do not use |
Other Information
- each teaspoonful (5 mL) contains: sodium 5 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Inactive Ingredients
anhydrous citric acid, D&C red #33, FD&C red #40, flavors, glycerin, high fructose corn syrup, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucrose
Questions Or Comments?
(800) 616-2471
Principal Display Panel
NDC 17856-6985-01
Diphenhydramine HCl
Oral Solution
Antihistamine
12.5 mg/5 mL
Institutional Dispensing only
Cherry Flavored
Alcohol Free
NDC 17856-6985-02
Diphenhydramine HCl
Oral Solution
Antihistamine
25 mg/5 mL
Institutional Dispensing only
Cherry Flavored
Alcohol Free
* Please review the disclaimer below.
