FDA Label for Allergy
View Indications, Usage & Precautions
Allergy Product Label
The following document was submitted to the FDA by the labeler of this product Accudial Pharmaceutical, Inc.. 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)5Ml = One Teaspoon
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 The Child Has
- a breathing problem such as chronic bronchitis
- glaucoma
- a sodium-restricted diet
When Using This Product
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- excitability may occur, especially in children
Directions
- take every 4 to 6 hours
- do not take more than 6 doses in 24 hours
- to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age
- specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device
| children under 2 years | do not use |
| children 2 to 5 years | do not use unless directed by a doctor |
| children 6 to under 12 years | 5 mL to 10 mL (1 to 2 teaspoonfuls) |
Other Information
each teaspoon contains:
- sodium 3 mg
- store between 20°-25°C (68°-79°F). Protect from light. Store in outer carton until contents used.
Inactive Ingredients
artificial flavor, citric acid, D&C red no. 33, FD&C red no. 40, glycerin, polysorbate 20, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol.
Questions?
877-434-2036
Principal Display Panel - 118 Ml Carton
CHILDREN'S
ACCUDIAL
ROTATING DOSING LABEL
ACCURATE DOSING
BY WEIGHT
Diphenhydramine HCl
Oral Solution
Anthistamine
FOR RELIEF OF
Sneezing
Itchy, Watery Eyes
Runny Nose
Itchy Throat
For Ages 6 to under 12
Alcohol & Sugar Free
Compares to Children's
Benadryl® Allergy.
CHERRY
FLAVOR
4 FL. OZ.
(118 mL)
NDC 45014-140-04
Allergy
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