FDA Label for Adult Allergy Relief Dye Free

View Indications, Usage & Precautions

Adult Allergy Relief Dye Free Product Label

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

Drug Facts



Active ingredient [in each 10 mL]

Diphenhydramine HCl, USP 25 mg


Purpose



Antihistamine


Uses



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

Warnings



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 chronic bronchitis
  • ▪glaucoma
  • ▪a sodium-restricted diet
  • ▪trouble urinating due to enlarged prostate
  • 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
  • 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 (1-800-222-1222) right away.


Directions



  • ▪measure only with dosing cup provided
  • ▪Keep dosing cup with product
  • ▪mL = milliliter
  • ▪do not take more than 6 doses in 24 hours
  •  Age (yr)

    Dose (mL)

    Adult and children 12 years and older

    10 mL to 20 mL (2 to 4 tsp) every 4 to 6 hrs

    Children under 12 years

    Do not use


Other Information



  • each 10 mL contains: sodium 30 mg
  • •store at room temperature. Store in outer carton until contents used
  • •do not refrigerate
  • •see bottom panel for lot number and expiration date
  • •protect from light
  • •ask a doctor before use if you have a sodium restricted diet.

Inactive Ingredients



anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose

Questions or Comments?

1-866-467-2748


Package Label-Principal Display Panel 4 Fl Oz (118 Ml Bottle)



NDC 0363-7100-04

Dye-Free

AdultAllergyRelief

Diphenhydramine HCl | Antihistamine

For Relief of:

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