1. Home
  2. Labeler Index
  3. Cdma Inc
  4. 63868-474
  5. Label Information: Allergy Relief Antihistamine

FDA Label for Allergy Relief Antihistamine

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH SOFTGEL)
    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. OVERDOSE WARNING
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL - 24 SOFTGEL BLISTER PACK CARTON

Allergy Relief Antihistamine Product Label

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

Other



Drug Facts

Distributed by C.D.M.A., Inc.©
43157 W 9 Mile Rd
Novi, MI 48375


Active Ingredient (In Each Softgel)



Diphenhydramine HCl 25mg


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



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

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 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


Overdose Warning



In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.


Directions



  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours.
    • adults and children 12 years of age and over1 to 2 softgel
    children 6 to under 12 years1 softgel
    children under 6 years of agedo not use this product

Other Information



  • store at room temperature between 20-25°C (68-77°F)
  • avoid excessive heat, humidity and light

Inactive Ingredients



gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide


Questions Or Comments?



Call: 1-888-577-8033 Monday - Friday 9am-4:30pm EST


Principal Display Panel - 24 Softgel Blister Pack Carton



QC®
QUALITY
CHOICE

NDC 63868-474-24

*Compare to the active
Ingredient in BENADRYL®
Allergy LIQUI-GELS®

Dye-Free

Allergy Relief

Antihistamine

* Please review the disclaimer below.