Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameDIPHENHYDRAMINE HYDROCHLORIDE
Labeler / manufacturerKROGER COMPANY
RouteORAL
Drug classDrug class not supplied in source label
Product NDC41226-710
Label effective date2026-09-02
Official product label reference
KROGER Dye Free Childrens Allergy Relief — KROGER COMPANY
This page contains 13 source sections for DIPHENHYDRAMINE HYDROCHLORIDE, oral route. Label set 2bea22e9-34b6-4961-94bb-5600dd90e891, version 4.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
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
Purpose
Purpose Antihistamine
Dosage and administration — label text
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.
Table text from source:
| 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
Warnings
Warnings 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 at 1-800-222-1222.
Active ingredient
Active ingredient (in each 5 mL) Diphenhydramine HCl USP 12.5 mg
Do not use
Do not use ▪ to make a child sleepy ▪ with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use
Ask a doctor before use if the child has ▪ a breathing problem such as chronic bronchitis ▪ glaucoma
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers
While using this medicine
When using this product ▪ marked drowsiness may occur ▪ sedatives and tranquilizers may increase drowsiness ▪ excitability may occur, especially in children
Child safety
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.
Storage and handling
Other information • each 5 mL contains : sodium 3 mg • store at room temperature • protect from sunlight • see bottom panel for lot number and expiration date • contains low sodium
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.