Active Ingredients
Diphenhydramine HCl 12.5 mg
Allergy Solution
FDA Label NDC 55910-124
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dolgencorp, Llc for the product Allergy (NDC 55910-124). 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 ingredients, 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:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
Do Not Use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Ask A Doctor Before Use If The Child Has
- a breathing problem such as chronic bronchitis
- glaucoma
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 right away.
Directions
- do not take more than directed
- find right dose on chart below
- mL = milliliter
- only use the dose cup provided
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 doses in 24 hours
| 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 |
Other Information
- each 5 mL contains: sodium 4 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum
Questions Or Comments?
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Compare to active
ingredient of
Children’s Benadryl®
Dye-Free Allergy*
For Ages 6 to 11 Years
Children's
Allergy
Diphenhydramine HCl
12.5 mg per 5 mL
Oral Solution
Antihistamine
Relieves:
• Sneezing
• Runny nose
• Itchy, watery eyes
• Itchy nose or throat
Dye free/Alcohol free
4 FL OZ (118 mL)
Bubble Gum
Flavor
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by
Kenvue Inc., owner of the registered trademark
Children’s Benadryl® Dye-Free Allergy.
50844 ORG012301836
DISTRIBUTED BY
OLD EAST MAIN CO.
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072
Dollar General 44-018 (Dollar General 44 018 1)
* Please review the disclaimer below.
