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Drug Facts
Quality Choice Solution
FDA Label NDC 83324-339
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 Quality Choice (NDC 83324-339). 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 throat or Nose
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 istaking 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 at 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 (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 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.
Questions Or Comments?
1-866-467-2748
Principal Display Panel
*Compare to the Active Ingredient in Children'sBenadryl ®Dye-Free
NDC 83324-339-04
Children’s Allergy Relief
Dye-Free
Diphenhydramine HCl ǀ Antihistamine
Oral solution
For Relief of:
- Runny Nose,
- Itchy Throat or Nose
- Sneezing and
- Itchy, Watery Eyes
Sugar-Free
Natural Cherry Flavor
4 FL. OZ. (118 mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING
*This product is not manufactured or distributed by Johnson and Johnson, owner of the registered trademark Children’s Benadryl ®Dye–Free.
IMPORTANT:Keep this carton for the future reference on full labeling. |
Distributed by: CDMA, INC,
Novi, MI 48375
Questions: 800-935-2362
Quality Choice Childrens Allergy Relief Dye Free 4 Fl Oz (Benadryl 01)
* Please review the disclaimer below.
