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Drug Facts
Target Dye Free Childrens Allergy Relief Syrup
FDA Label NDC 82442-710
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Target Corporation for the product Target Dye Free Childrens Allergy Relief (NDC 82442-710). 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 other, active ingredient (in each 5 ml), purpose, uses, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each 5 Ml)
Diphenhydramine HCl USP 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
Otc - Do Not Use
Do not use
▪ to make a child sleepy▪ with any other product containing diphenhydramine, even one used on skin
Otc - Ask Doctor
Ask a doctor before use if the child has
▪ a breathing problem such as chronic bronchitis▪ glaucoma
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers
Otc - When Using
When using this product
▪ marked drowsiness may occur▪ sedatives and tranquilizers may increase drowsiness▪ excitability may occur, especially in children
Otc - Keep Out Of Reach Of Children
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▪ take every 4 to 6 hours, or as directed by a doctor▪ do not take more than 6 doses in 24 hours▪ mL = milliliter
Age (yr) | Dose (tsp) |
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 designed for use with this product. Do not use any other dosing device.
Other Information
▪ each 5 mL contains: sodium 3 mg▪ store at room temperature▪ see bottom panel for lot number and expiration date▪ protect from light▪ contains low sodium
Inactive Ingredients
anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.
Principal Display Panel
NDC 82442-710-08
Compare to active ingredient in Children's
Benadryl® Dye-Free
Dye-Free
Children’s Allergy Relief
Diphenhydramine HCl / Antihistamine
Oral solution
For Relief of:
Sugar Free
Natural Cherry Flavor
8 fl oz (236 mL)
*This product is not manufactured or distributed by Johnson & Johnson, owner of the registered trademark Children’s Benadryl® Dye –Free.
IMPORTANT: Keep this carton for future reference on full labelling.
TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING
Distributed by:
Target Dye-free Childrens Allergy Relief (Benadryl 01)
* Please review the disclaimer below.
