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  5. Label Information: Diphenhydramine Hydrochloride

FDA Label for Diphenhydramine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THIS PRODUCT
    8. IF PREGNANT OR BREAST-FEEDING,
    9. KEEP OUT OF REACH OF CHILDREN.
    10. INACTIVE INGREDIENTS
    11. QUESTIONS OR COMMENTS?

Diphenhydramine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Richmond Pharmaceuticals Inc.. 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.

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
  • sneezing
  • itchy nose or throat
  • 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.


Inactive Ingredients



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


Questions Or Comments?



call 804-270-4498, 8:30 am - 4:30 pm ET, Monday – Friday

TAMPER EVIDENT: DO NOT USE IF BLISTER PACK IS TORN OR DAMAGED

*Richmond Pharmaceuticals, Inc. is not affiliated with the owner of the trademark BENADRYL® Allergy.

Distributed by: Richmond Pharmaceuticals Inc., Richmond, VA 23233 Made in USA

RI1010

Principle Display Panel

Richmond Pharmaceuticals, Inc.

*Compare to active ingredient in BENADRYL® Allergy

Diphenhydramine HCI Capsules, USP

25 mg
50 mg

ANTIHISTAMINE

100 CAPSULES (10 x 10)


* Please review the disclaimer below.