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FDA Label for Allergy

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH 5 ML = 1 TEASPOON)
    3. PURPOSE
    4. USES
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF THE CHILD HAS
    7. OTC - ASK DOCTOR/PHARMACIST
    8. WHEN USING THIS PRODUCT
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. OVERDOSE WARNING
    11. OTHER INFORMATION
    12. DIRECTIONS
    13. QUESTIONS?
    14. INACTIVE INGREDIENTS
    15. PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE LABEL

Allergy Product Label

The following document was submitted to the FDA by the labeler of this product Accudial Pharmaceutical, 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: AccuDial® Pharmaceutical, Inc. Palm Beach Gardens, FL 33408


Active Ingredient (In Each 5 Ml = 1 Teaspoon)



Diphenhydramine, USP HCl 12.5 mg.


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 The Child Has



  • a breathing problem such as chronic bronchitis
  • glaucoma
  • a sodium-restricted diet

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers.

Consult your pharmacist or health care provider for any appropriate, additional dosage delivery device necessary for use when a physician recommends a dose that is different than the doses that appear on the dosage delivery device that accompanies this product.

Age (yr)Dose (TSP)
TSP = teaspoon
under 6 yrs.ask a doctor
6 to under 121-2 TSP
or as directed by a doctor

When Using This Product



  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children.

Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Overdose Warning



Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms.


Other Information



  • each teaspoon contains: sodium 7 mg
  • store between 20°-25°C (68°-77°F)
  • tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.

Directions



  • may be given every 4 to 6 hours
  • do not use more than 6 times in 24 hours
  • use only enclosed dosing cup to dose this product. Do not use any other dosing device.

Questions?



877-434-2036


Inactive Ingredients



artificial flavor, citric acid anhydrous, CMC sodium, glycerin, polysorbate, propylene glycol, purified water, sodium benzoate, sodium saccharin, sodium citrate dihydrate, sorbitol solution.


Principal Display Panel - 118 Ml Bottle Label



ACCUDIAL®

Children's
Allergy

Diphenhydramine HCl
Oral Solution Antihistamine

Relieves Sneezing
• Itchy, Watery Eyes
Runny Nose • Itchy Throat

Earth-Friendly
Package!

For Ages 6 yrs to under 12 yrs

Tamper Evident

Compares to Children's
Benadryl® Allergy

Dye-Free
BUBBLEGUM
FLAVOR

NDC 45014-161-04
4 FL. OZ. (118 mL)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label - allergy 01

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label - allergy 01


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