Allergy relief

Manufacturer
NORTHEAST PHARMA | Geri-Care Pharmaceutical Corp
Effective date
2023-11-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:20:32

Label at a glance#

ProductAllergy relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

do not exceed recommended dose adults and children 12 years and over, take 1 to 2 tablets every 4-6 hours, as needed; not more than 12 tablets in 24 hours, or as directed by a doctor children under 12 years: consult a doctor

Storage and handling

each tablet contains: calcium 30 mg store at 20-25°C (68-77°F); excursions permitted between 15°C - 30°C (59°F - 86°F) protect from moisture Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

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

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

When using this product

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • use caution 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not exceed recommended dose
  • adults and children 12 years and over, take 1 to 2 tablets every 4-6 hours, as needed; not more than 12 tablets in 24 hours, or as directed by a doctor
  • children under 12 years: consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 30 mg
  • store at 20-25°C (68-77°F); excursions permitted between 15°C - 30°C (59°F - 86°F)
  • protect from moisture
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

cellulose, D&C red #27 lake, dicalcium phosphate, magnesium stearate, PEG, polyvinyl alcohol, silica, starch, stearic acid, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80136-683ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, COATED [NORTHEAST PHARMA]1Unmatched20231116_0a33f9a9-1fa8-7cdf-e063-6294a90adca1.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80136-68380136-683-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
452643cd-a177-82b7-e063-6394a90af43d0a33f9a9-1fa8-7cdf-e063-6294a90adca12025-12-04WarningsExact identifier
spl set id: 0a33f9a9-1fa8-7cdf-e063-6294a90adca1

Reported adverse events (FAERS/openFDA)#

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