FDA Label for Diphenhydramine
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 5 ML)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF THE CHILD HAS
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS
- WHEN USING THIS PRODUCT
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE LABEL
Diphenhydramine Product Label
The following document was submitted to the FDA by the labeler of this product Central Texas Community Health Centers. 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 5 Ml)
Diphenhydramine HCl 12.5 mg
Purpose
Antihistamine
Uses
• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:• sneezing• itching of the nose or throat• runny nose• itchy, watery eyes
Do Not Use
• with any other product containing diphenhydramine, even one used on skin• to make a child sleepy
Ask A Doctor Before Use If The 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• excitability may occur, especially in children• sedatives and tranquilizers may increase drowsiness
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
• find right dose on chart below• mL = milliliter• take every 4 to 6 hours, or as directed by a doctor• do not take more than 6 doses in 24 hours
Age (yr) | Dose (mL) |
children under 2 years | do not use |
children 2 to 5 years | do not use unless directed by a doctor |
children 6 to 11 years | 5 mL to 10 mL |
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
Other Information
• each 5 mL contains: sodium 15 mg• store at 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.• do not use if printed neckband is broken or missing
Inactive Ingredients
anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution
Questions Or Comments?
1-800-719-9260
Principal Display Panel - 118 Ml Bottle Label
Austin/Travis Co. Health & Human Services Dept.
Diphenhydramine
Soln.118ml
Date:
Name:
Dr.
USE AS DIRECTED
1/1/01
123456
Diphenhydramine Sol.12.5mg/5ml #118ml 76413-333-01
Batch: 123456
Lot: 123456
Exp: 1/1/01
SUNMARK
Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.
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