FDA.reportPublic FDA data

Allergy Relief

Manufacturer
PLD Acquisitions LLC DBA Avéma Pharma Solutions
Effective date
2023-02-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:37:03

Label at a glance#

ProductAllergy Relief Antihistamine
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 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 common cold: runny nose sneezing 

Dosage and administration

take every 4 to 6 hours or as directed by a doctor do not take more than 6 doses in 24 hours  adults and children 12 years and over take 1 to 2 tablets   children 6 to under 12 years take 1 tablet children under 6 years do not use 

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 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 common cold:
    • runny nose
    • sneezing 

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • 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,

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 to 6 hours or as directed by a doctor
  • do not take more than 6 doses in 24 hours
 adults and children 12 years and overtake 1 to 2 tablets 
 children 6 to under 12 yearstake 1 tablet
children under 6 years do not use 

Other information

OTHER SAFETY INFORMATION

  • each tablet contains: calcium 25 mg
  • store between 20-25°C (68-77°F)
  • protect from light and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, D&C Red #27 Aluminum Lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Benadryl® Allergy**

Allergy Relief

Diphenhydramine HCl 25 mg • Antihistamine

Relieves

  • Runny Nose
  • Sneezing
  • Itchy,Watery Eyes
  • Itchy Nose or Throat

Tablets

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

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Manufactured by:

Avema Pharma Solutions

10400 NW 29th Terrace

Miami, FL 33172

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Allergy Relief
Allergy Relief

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63548-0690-12023-02-09C16284748780-1f386c649-bd24-0266-e053-dadaa90a7c1aDrug Facts
63548-0690-12023-01-30C16284748780-1f386c649-bd24-0266-e053-dadaa90a7c1aDrug Facts

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
63548-069063548-0690-1

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C RED NO. 272LRS185U6KIACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEO7TSZ97GEPIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ALUMINUM OXIDELMI26O6933IACT

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
e194dafc-ebc7-48a6-b53c-652798eab942c9b9fbc0-d936-4801-ab58-1339a4cfcf3a2023-02-09WarningsExact identifier
spl id: e194dafc-ebc7-48a6-b53c-652798eab942
spl set id: c9b9fbc0-d936-4801-ab58-1339a4cfcf3a

Reported adverse events (FAERS/openFDA)#

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