FDA Label for Cvs Pharmacy Pre-measured Spoon Childrens Allergy Medication

View Indications, Usage & Precautions

Cvs Pharmacy Pre-measured Spoon Childrens Allergy Medication Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy, 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


Active Ingredient (In Each 5 Ml)*



Diphenhydramine HCl 12.5 mg

*5 mL = one pre-filled spoon


Purpose



Antihistamine


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

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
  • trouble urinating due to an enlarged prostate gland
  • a sodium-restricted diet

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. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Directions



  • refer to chart below
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
  • Children under 2 years of agedo not use
    Children 2 to 5 years of agedo not use unless directed by a doctor
    Children 6 to 11 years of age1 to 2 pre-filled spoons (12.5 mg to 25 mg)
    Adults and children 12 years of age and over2 to 4 pre-filled spoons (25 mg to 50 mg)

Other Information



  • each pre-filled spoon contains: sodium 14 mg
  • store between 20-25°C (68-77°F).
  • Protect from light. Store in outer carton until contents used.
  • SAFETY SEALED: This product is protected by a sealed pouch. Do not use if individual foil pouch is torn or damaged

Inactive Ingredients



anhydrous citric acid, D&C red #33, FD&C red #40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose


Questions Or Comments?



Call 877-545-3635

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Benadryl® Allergy Perfect Measure


Principal Display Panel



NDC 59779-044-10

CVS Pharmacy Pre-measured spoon
Children's
ALLERGY LIQUID MEDICATION
®


Diphenhydramine HCI
Oral Solution Antihistamine

Relieves:

* Please review the disclaimer below.