Active Ingredient (In Each 5 Ml)
Diphenhydramine HCl 12.5 mg
Childrens Dye Free Allergy Liquid
FDA Label NDC 49580-0293
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by P & L Development, Llc for the product Childrens Dye Free Allergy (NDC 49580-0293). 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 drug 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 chart below
| Age (yr) | Dose (mL) |
| children 6 to 11 years | 5mL 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,carboxymethyl cellulose sodium, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to active ingredient in Children's Benadryl® Allergy*
Children's
dye-free
allergy
Diphenhydramine HCl 12.5 mg
Antihistamine
relieves:
- sneezing
- runny nose
- itchy, watery eyes
- itching of the nose or throat
For Ages 6 to 11
alcohol free
dye-free
bubblegum Flavor
FL OZ (mL)
Dosing Cup Included
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl® Allergy.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.
Manufactured by:
PL Developments
11865 S. Alameda St
Lynwood, CA 90262
Package Label
Readyincase Children's Dye-Free Allergy
* Please review the disclaimer below.
