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  5. Label Information: Diphenhydramine

FDA Label for Diphenhydramine

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. OTC - ASK DOCTOR
    5. OTC - DO NOT USE
    6. OTC - WHEN USING
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DOSAGE & ADMINISTRATION
    10. STORAGE AND HANDLING
    11. INACTIVE INGREDIENT
    12. HOW SUPPLIED
    13. OTHER SAFETY INFORMATION
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diphenhydramine Product Label

The following document was submitted to the FDA by the labeler of this product Purinepharma Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredient (each banded capsule contains)
Diphenhydramine HCL 25 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 58599-003-90
NDC 58599-003-25
NDC 58599-003-29
NDC 58599-003-35

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

50000 Capsules - capsules 25mg 50000ct

50000 Capsules - capsules 25mg 50000ct


* Please review the disclaimer below.