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Drug Facts
Dye Free Childrens Allergy Relief Solution
FDA Label NDC 49035-600
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores Inc. for the product Dye Free Childrens Allergy Relief (NDC 49035-600). 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▪ Itchy 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 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 (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 | 5mL 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 Children'sBenadryl® Dye-Free active ingredient
NDC 49035-600-04
Dye-Free
Children’s Allergy Relief
Diphenhydramine HCl USP 12.5 mg ǀ Antihistamine
Oral solution
For Relief of:
- Runny Nose,
- Sneezing
- Itchy, Watery Eyes
- Itchy Throat or Nose
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:
Walmart Inc.,
Bentonville, AR 72716
Dye Free Chidlrens Allergy Relief Diphenhydramine (Benadryl 01)
* Please review the disclaimer below.
