Allergy Relief

Manufacturer
KRAMER NOVIS
Effective date
2020-03-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:03:53

Label at a glance#

ProductAllergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and 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 Temporarily relieves these symptoms due to the common cold: • runny nose • sneezing

Dosage and administration

• Take every 4 to 6 hours, or as directed by doctor. • Do not exceed recommended dose.  Adults and Children 12 years of age and over:  take 10 to 20 mL (2 to 4 tsp) not to exceed 300 mg in 24 hours  Children 6 to under 12 years of age:  take 5 to 10 mL (1 to 2 tsp) not to exceed 150 mg in 24 hours  Children under 6 years of age:  consult a doctor

Storage and handling

• Store at controlled room temperature 15°-30°C (59°-86°F). • Do not refrigerate. Avoid excessive heat or humidity. • Protect from light. 

Label contents#

Full prescribing information#

Active Ingredient (in each 5 mL tsp)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCL, 12.5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

Temporarily relieves these symptoms due to the common cold:
• runny nose • sneezing

Warnings

WARNINGS SECTION

Do not use

• with any other product containing diphenhydramine, even one used on skin

• to make a child sleepy

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis

• glaucoma

• trouble urinating due to the enlarged prostate gland

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

When using this product:

• excitability might occur, especially in children

• marked drowsiness may occur • avoid alcoholic drinks

• alcohol, sedatives, and tranquilizers may increase drowsiness effect

• be careful when driving a motor vehicle or operating machinery

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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 

Directions

DOSAGE & ADMINISTRATION SECTION

• Take every 4 to 6 hours, or as directed by doctor.
• Do not exceed recommended dose.

 Adults and Children 12 years of age and over: take 10 to 20 mL (2 to 4 tsp) not to exceed 300 mg in 24 hours
 Children 6 to under 12 years of age: take 5 to 10 mL (1 to 2 tsp) not to exceed 150 mg in 24 hours
 Children under 6 years of age: consult a doctor

Other information

STORAGE AND HANDLING SECTION

• Store at controlled room temperature 15°-30°C (59°-86°F).

• Do not refrigerate. Avoid excessive heat or humidity.

• Protect from light. 

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cherry flavor, citric acid, FD&C Red #40, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sorbitol, and sucralose

Questions or comments?

OTC - QUESTIONS SECTION

Call weekdays from 8 AM to 4 PM AST at 1-787-767-2072 | www.kramernovis.com

Manufactured in the USA for Kramer Novis, San Juan, PR 00917

SPL UNCLASSIFIED SECTION

Compare to the active ingredient of Benadryl®  Allergy Liquid*

Relieves:

√  Runny Nose

√  Sneezing

√  Itchy, Watery Eyes

√  Itchy Throat

Cherry Flavor

Alcohol Free

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl® Allergy.

TAMPER EVIDENT: DO NOT USE IF SEAL UNDER CAP IS TORN, BROKEN OR MISSING.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN1
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD1
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY1
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY1
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY1

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52083-665-162023-01-30C16284748780-1f386c649-e6a9-0266-e053-dadaa90a7c1aAllergy Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52083-665-16Allergy Relief473 mL in 1 BOTTLELIQUID4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52083-665ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [KRAMER NOVIS]1Legacy NDC, 1 package rows20200307_b055e3cc-a666-4140-b58e-face4dd76423.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52083-66552083-665-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML · Source PDF

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
7d392208-3e6a-484e-b6be-6faf23668c97b055e3cc-a666-4140-b58e-face4dd764232020-03-03WarningsExact identifier
spl id: 7d392208-3e6a-484e-b6be-6faf23668c97
spl set id: b055e3cc-a666-4140-b58e-face4dd76423

Reported adverse events (FAERS/openFDA)#

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