1. Home
  2. Labeler Index
  3. Kroger Company
  4. 30142-832
  5. Label Information: Allergy Antihistamine

FDA Label for Allergy Antihistamine

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH BANDED CAPSULE)
    3. PURPOSE
    4. USES
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. OTC - ASK DOCTOR/PHARMACIST
    8. WHEN USING THIS PRODUCT
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS
    15. PRINCIPAL DISPLAY PANEL - 25 MG CAPSULE BOTTLE CARTON

Allergy Antihistamine Product Label

The following document was submitted to the FDA by the labeler of this product Kroger Company. 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.

Other



Drug Facts


Active Ingredient (In Each Banded Capsule)



Diphenhydramine HCl 25 mg


Purpose



Antihistamine


Uses



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

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



  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Otc - Ask Doctor/Pharmacist



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


When Using This Product



  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution 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.


Directions



  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
    • adults and children 12 years and over1 to 2 capsules
    children 6 to under 12 years1 capsule
    children under 6 yearsdo not use

Other Information



  • store at room temperature between 20-25 °C (68-77 °F)

Inactive Ingredients



butylparaben, D&C Red #28, FD&C Blue #1, FD&C Red #40, gelatin, lactose monohydrate, magnesium stearate, methylparaben, polysorbate 80, propylparaben, purified water, sodium lauryl sulphate, starch


Questions Or Comments



1-800-632-6900


Principal Display Panel - 25 Mg Capsule Bottle Carton



*Compare to active ingredient in Benadryl®

NDC 30142-832-84

Allergy
Capsules

Diphenhydramine HCl
25 mg
ANTIHISTAMINE

RELIEVES:
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat

100
CAPSULES

PRINCIPAL DISPLAY PANEL - 25 mg Capsule Bottle Carton - kroger 01

PRINCIPAL DISPLAY PANEL - 25 mg Capsule Bottle Carton - kroger 01


* Please review the disclaimer below.