Active Ingredient (In Each 5 Ml)
Diphenhydramine HCl 12.5 mg
Dye Free Allergy Liquid
FDA Label NDC 63868-128
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Quality Choice (chain Drug Marketing Association) for the product Dye Free Allergy (NDC 63868-128). 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 the child has, ask a doctor or pharmacist before use if the child is, when using this product, keep out 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
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- sneezing
- runny nose
- itchy, watery eyes
- itching of the nose or throat
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
- sedatives and tranquilizers may increase drowsiness
- excitability may occur, especially in children
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- do not take more than 6 doses in 24 hours
- take every 4 to 6 hours, or as directed by a doctor
- measure only with dosing cup provided. Do not use any other dosing device.
- mL = milliliter
- keep dosing cup with product
- find the right dose on the chart below
| age (yr) | dose (mL) |
| children 6 to 11 years | 5 mL to 10 mL |
| children 2 to 5 years | do not use unless directed by a doctor |
| children under 2 years | do not use |
Other Information
- each 5 mL contains: sodium 8 mg
- store between 20-25°C (68-77°F). Do not refrigerate.
- Protect from light. Store in outer carton until contents are used.
Inactive Ingredients
anhydrous citric acid, carboxymethycellulose sodium, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol
Questions Or Comments?
Call 1-248-449-9300 Monday-Friday 9AM-5PM EST
Principal Display Panel
*Compare to the active ingredient in Children's Benadryl® Allergy
Dye-Free
Children's
Allergy
Antihistamine
Sugar & Alcohol Free
Diphenhydramine Hydrochloride 12.5mg / 5 mL
Oral Solution
Liquid Medication
Relieves
Runny Nose | Sneezing |
Itchy, Watery Eyes | Itchy Throat
For Ages 6 to 11 Years
Alcohol-Free
Dye-Free
Bubble Gum Flavored
FL OZ (mL)
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributors of Benadryl® Allergy.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
Distributed by C.D.M.A., Inc,©
43157 W.Nine Mile
Novi, MI 48376-0995
Package Label
QUALITY CHOICE Dye-Free Children's Allergy
* Please review the disclaimer below.
