Diphenhydramine HCl 12.5 mg per 5 mL Oral Solution Dye Free - Bubblegum Flavor

Manufacturer
BETTER LIVING BRANDS LLC. | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2026-10-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-11-13 02:01:57

Label at a glance#

ProductCHILDRENS DYE FREE ALLERGY RELIEF
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure15 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

OTC - PURPOSE SECTION

Purpose

Antihistamine

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

OTC - ASK DOCTOR SECTION

Ask a doctor before use if the child has

  • a breathing problem such as chronic bronchitis
  • glaucoma

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

OTC - WHEN USING SECTION

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 SECTION

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).

DOSAGE & ADMINISTRATION SECTION

Directions

  • find right dose on chart below
  • mL = milliliter
  • 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

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

OTHER SAFETY INFORMATION

Other information

  • each 5 mL contains: sodium 5 mg
  • store at no greater than 25°C

INACTIVE INGREDIENT SECTION

Inactive ingredients anhydrous citric acid, flavors, glycerin, purified water, sodium benzoate, sodium carboxymethylcellulose, sodium citrate dihydrate, sodium saccharin, sorbitol solution, sucralose

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diphenhydramine HCl 12.5mg / 5 ml Label

Albertsons 653L labelAlbertsons 653L label

Diphenhydramine HCL 12.5mg / 5 ml Carton

Albertsons 653L cartonAlbertsons 653L carton

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21130-55821130-558-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 16 · 303 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy3d71d306-893a-e73a-e063-6394a90a0a3b2026-10-23WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDERaritan Pharmaceuticals Inc303d7651-9c8f-4a14-9f2c-7181fa0f003e2026-09-09WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
VICKS ZzzQuil NIGHTTIME SLEEP-AID Diphenhydramine HCl FREE OFDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company01906eed-78ee-f2a1-e063-6294a90a809b2026-09-08WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
KROGER Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANYa26d63db-8841-47a4-ae09-ac736d7ec3572026-09-02WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
KROGER Dye Free Childrens Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANY2bea22e9-34b6-4961-94bb-5600dd90e8912026-09-02WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEKroger514aa6b5-c33b-494c-e063-6294a90a7ace2026-08-27WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEAmazon.com Services LLC298e9164-e378-4b39-a944-bfc8f8baa4de2026-08-27WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
HyVee Maximum Strength Nighttime Sleep-Aid SOFTGELDIPHENHYDRAMINE HYDROCHLORIDEHyVee Inc496ce4ba-08a9-ee99-e063-6294a90ac9a72026-08-21WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst9713d8ee-6ab2-2fdf-e053-2a95a90a9e192026-08-19Warnings, Adverse reactionsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.a575a914-14a0-442c-a504-ac7a0aa0ac772026-08-18WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.e8785ba8-e53e-491e-bbfe-04e860f361312026-08-18WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.9f944edc-a317-4967-ae54-67b5d183591b2026-08-18WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
CVS dye-free childrens allergyDIPHENHYDRAMINE HYDROCHLORIDECVS PHARMACYdb5a5eff-1bb1-4d00-8c01-caae7a1c72232026-08-17WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp4b6fc81e-e3ba-4a36-834c-82766311aa732026-08-17WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp8db277e2-9d98-40b6-8000-a51c57fb4ece2026-08-14WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDEWINCO FOODS, LLC6fb6cfde-30a6-419c-973d-8abdc72611ed2026-08-07WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 107, LLC887cabe5-46d0-4f4e-8f5a-2cfdbc157b582026-08-07WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Winco Foods Childrens Allergy Relief Dye FreeDIPHENHYDRAMINE HYDROCHLORIDEWINCO FOODS, LLCa1367804-37c9-4906-858f-8feeb748d8d32026-08-07WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine HCLDIPHENHYDRAMINE HYDROCHLORIDERedmont Pharmaceuticals, LLCd8944f3c-acef-4ebe-9633-7d641ae95edf2026-08-03Warnings, Adverse reactionsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DG Health Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEDolgencorp Inced754d5c-74e1-4dee-a5c5-10ccec1b81db2026-08-03WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.