Diphenhydramine Hydrochloride
FDA Label NDC 69206-995

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aventura Pharmaceuticals, Llc for the product Diphenhydramine Hydrochloride (NDC 69206-995). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses, warnings, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

.

Active Ingredient

(in each capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

  • runny nose
  • itchy nose or throat
  • sneezing
  • itchy, watery eyes

Warnings

Do not use 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

  • you may get very drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives & 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.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 12 years and over: take 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours
  • children under 12 years: ask a doctor

Other Information

  • store at 15-30 °C (59-86 °F)
  • protect from moisture

Inactive Ingredients

benzyl alcohol, butylparaben, D&C red# 28, edible black ink, FD&C bule #1, FD&C red# 40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium laurel sulfate

Questions Or Comments

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED

Distributed by: Aventura Pharmaceuticals, LLC

Package Label.Principal Display Panel

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, USP 25 MG

ANTIHISTAMINE

NDC: 69206-995-01 – 100 COUNT

Container Label (Aventura Sample Label)

Container Label (Aventura Sample Label)

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