Diphenhydramine
FDA Label NDC 58599-004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Purinepharma Llc for the product Diphenhydramine (NDC 58599-004). 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 otc - active ingredient, otc - purpose, indications & usage, otc - ask doctor, otc - do not use, otc - when using, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient (each banded capsule contains)
Diphenhydramine HCL 50 mg

Otc - Purpose

Purpose
Antihistaminne

Indications & Usage

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

Otc - Ask Doctor

Ask a doctor before use if you have

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

Otc - Do Not Use

Do not use to make a child sleepy

Do not use with any other product containing diphenhydramine, even one used on skin

Otc - When Using

When using this product

  • 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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children, In case of overdose, get medical help or contact a Poison control center right away.

Dosage & Administration

Directions:

  • Take every 4 to 6 hours.
  • Do not take more than 6 doses in any 24-hour period.
    • Adults and Children 12 years of age and over1 to 2 capsules
    Children 6 to under 12 years of age1 capsule
    Children under 6 years of ageDo not use

Storage And Handling

Other information

  • Store between 15-30 degree Celsius (59-86 degree Fahrenheit)
  • Protect from moisture

Inactive Ingredient

D&C red 28, gelatin, lactose monohydrate, magnesium stearate, maize starch, polysorbate tween 80, silica gel.

How Supplied

Pack Size: 50 Capsules in a Bottle
Batch No.:
Mfg. Date:
Exp. Date:

Other Safety Information

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING.

Package Label.Principal Display Panel

NDC 58599-004-90
NDC 58599-004-25
NDC 58599-004-29
NDC 58599-004-35

Manufactured By: PURINEPHARMA LLC
5 County Route 42
Massena, NY – 13662
www.purinepharma.com

50000 Capsules (Capsules 50mg 50000ct)

50000 Capsules (Capsules 50mg 50000ct)

Carton For 50 Capsules In A Bottle (Carton 50mg 50ct)

Carton For 50 Capsules In A Bottle (Carton 50mg 50ct)

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