FDA.reportPublic FDA data

Allergy Relief - Health Pharma USA LLC

Manufacturer
Health Pharma USA LLC
Effective date
2026-07-07
Label type
HUMAN OTC DRUG LABEL
Version
32
Source
weekly-update
Hydrated at
2026-07-17 21:43:41

Label at a glance#

ProductAllergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure14 sections

Indications and uses

Temporarily relieves Sneezing, runny nose, itchy, watery eyes, and itchy throat.

Dosage and administration

Adults and children 12 years  and over: 1 or 2 caplet (s) Children 6 to under 12 years of age: 1 caplet Children under 6 years of age: do not use; Do not take more than 6 caplets a day.

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses:

INDICATIONS & USAGE SECTION

  • Temporarily relieves Sneezing, runny nose, itchy, watery eyes, and itchy throat.

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

  • Trouble urinating due to an enlarged prostate gland
  • Glaucoma 
  • 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, may cause drowsy.
  • Excitability may occur, especially in children. 
  • Be careful when driving a motor vehicle or operating machinery.

Stop use and ask doctor ifsymptoms not relieved within seven days usage, please contact physician or health care provider.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years  and over:1 or 2 caplet (s)
Children 6 to under 12 years of age:1 caplet
Children under 6 years of age:do not use; Do not take more than 6 caplets a day.

Other Information

OTHER SAFETY INFORMATION

  • Store at controlled room temperature 20°-25°C (68°-77°F).
  • Read all product information before use.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

May Contains:

Colloidal Silicon Dioxide, Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose, D&C Red 27, Polyvinyl alcohol, Talc, Titanium dioxide, Polyethylene Glycol, Lecithin, Purified waer.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free  1-844-832-1138

Monday through Friday 9AM- 5PM EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-100 count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-300 count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-600 count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-1000 count

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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

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
71679-10671679-106-01, 71679-106-03, 71679-106-06, 71679-106-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
D&C RED NO. 272LRS185U6KIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TALC7SEV7J4R1UIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
312025-06-24full-release2026-06-01 01:03:58

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
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHealth Pharma USA LLCd38f47ea-7fda-170b-e053-2995a90adc822026-07-07WarningsExact identifier
ndc (package): 71679-106-10
ndc (package): 71679-106-06
ndc (package): 71679-106-01
ndc (package): 71679-106-03
ndc (product): 71679-106
ndc11 (package): 71679010601
ndc11 (package): 71679010603
ndc11 (package): 71679010610
ndc11 (package): 71679010606
spl id: 55feb1c4-8bfd-1cd5-e063-6394a90af306
spl set id: d38f47ea-7fda-170b-e053-2995a90adc82

Reported adverse events (FAERS/openFDA)#

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