Allergy by Accudial Pharmaceutical, Inc.
Medically reviewed on February 6, 2018
Dosage form: liquid
Ingredients: Diphenhydramine Hydrochloride 12.5mg in 5mL
Labeler: Accudial Pharmaceutical, Inc.
NDC Code: 45014-161
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Diphenhydramine, USP HCl 12.5 mg.
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- itching of the nose or throat
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
- a breathing problem such as chronic bronchitis
- a sodium-restricted diet
Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers.
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- excitability may occur, especially in children.
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 12||1-2 TSP|
|or as directed by a doctor|
Keep out of reach of children.
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.
- 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.
- 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.
artificial flavor, citric acid anhydrous, CMC sodium, glycerin, polysorbate, propylene glycol, purified water, sodium benzoate, sodium saccharin, sodium citrate dihydrate, sorbitol solution.
Distributed by: AccuDial® Pharmaceutical, Inc. Palm Beach Gardens, FL 33408
Oral Solution Antihistamine
• Itchy, Watery Eyes
Runny Nose • Itchy Throat
For Ages 6 yrs to under 12 yrs
Compares to Children's
4 FL. OZ. (118 mL)
diphenhydramine hydrochloride liquid
|Labeler - Accudial Pharmaceutical, Inc. (831999201)|
|Bio-Pharm, Inc.||801652546||ANALYSIS(45014-161), MANUFACTURE(45014-161), RELABEL(45014-161), REPACK(45014-161)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.
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