Allergy Relief Antihistamine

Manufacturer
CDMA Inc
Effective date
2024-12-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:50:08

Label at a glance#

ProductAllergy Relief Antihistamine
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: •  runny nose  •  itchy, watery eyes  • sneezing  • itching of the nose or throat temporarily relieves these symptoms due to the common cold: •  runny nose  • sneezing

Dosage and administration

• take every 4 to 6 hours • do not take more than 6 doses in 24 hours. adults and children 12 years of age and over   1 to 2 softgel children 6 to under 12 years   1 softgel children under 6 years of age   do not use this product

Storage and handling

• store at room temperature between 20-25°C (68-77°F)   • avoid excessive heat, humidity and light

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
•  runny nose  • itchy, watery eyes  • sneezing  • itching of the nose or throat
temporarily relieves these symptoms due to the common cold: • runny nose  • sneezing

Warnings

WARNINGS SECTION

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 you have:
• glaucoma    • trouble urinating due to an enlarged prostate gland    • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product:
• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

OVERDOSAGE SECTION

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

• take every 4 to 6 hours • do not take more than 6 doses in 24 hours.

adults and children 12 years of age and over  1 to 2 softgel
children 6 to under 12 years  1 softgel
children under 6 years of age  do not use this product

Other information

STORAGE AND HANDLING SECTION

• store at room temperature between 20-25°C (68-77°F)   • avoid excessive heat, humidity and light

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible white ink, gelatin, glycerin, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution

Questions or Comments?

OTC - QUESTIONS SECTION

Call: 1-888-577-8033 Monday - Friday 9am-4:30pm EST

SPL UNCLASSIFIED SECTION

QC®
QUALITY CHOICE

*Compare to the active Ingredient in BENADRYL® Allergy LIQUI-GELS®

Dye-Free

• Relieves sneezing
• Itchy, watery eyes
• Runny nose
• Itchy throat

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl®,or Catalent Pharma Solutions, Inc., owner of the registered trademark LIQUI-GELS®.

QC 100% SATISFACTION GUARANTEED

Distributed by C.D.M.A., Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362

Product of UAE

Packaged and Quality assured in USA

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

REV.01-092022

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CDMA-474CDMA-474

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN4
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-474-24Allergy Relief Antihistamine2 in 1 CARTONCAPSULE, LIQUID FILLED24
63868-474-24Allergy Relief Antihistamine12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-474ALLERGY RELIEF ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CDMA INC]4Legacy NDC, 2 package rows20250101_c5fdd413-912f-4f80-8376-2dd6c4eabbde.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-474-24EA - Each63868-4747d6e2855-81f4-4101-b552-ec077ac8978d12022-09-12

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-47463868-474-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
658041e9-a013-445b-bf46-e2e0eb253e53c5fdd413-912f-4f80-8376-2dd6c4eabbde2024-12-16WarningsExact identifier
spl id: 658041e9-a013-445b-bf46-e2e0eb253e53
spl set id: c5fdd413-912f-4f80-8376-2dd6c4eabbde

Reported adverse events (FAERS/openFDA)#

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