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Name: Allergy Manufacturer: Accudial Pharmaceutical, Inc. Category: Over-the-counter (OTC) Marketed Drugs
diphenhydramine hydrochloride liquid Accudial Pharmaceutical, Inc.
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.
Active ingredient (in each 5 mL)
Diphenhydramine HCl 12.5 mg
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
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
a sodium-restricted diet
Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers
When using this product
marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness
excitability may occur, especially in 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)
take every 4 to 6 hours
do not take more than 6 doses in 24 hours
to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age
specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device
children under 2 years
do not use
children 2 to 5 years
do not use unless directed by a doctor
children 6 to under 12 years
5 mL to 10 mL
(1 to 2 teaspoonfuls)
each teaspoon contains:
sodium 3 mg store between 20°-25°C (68°-79°F). Protect from light. Store in outer carton until contents used.
artificial flavor, citric acid, D&C red no. 33, FD&C red no. 40, glycerin, polysorbate 20, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol.
PRINCIPAL DISPLAY PANEL - 118 mL Carton
ROTATING DOSING LABEL
ACCURATE DOSING BY WEIGHT
Diphenhydramine HCl Oral Solution Anthistamine
FOR RELIEF OF
Sneezing Itchy, Watery Eyes Runny Nose Itchy Throat
For Ages 6 to under 12
Alcohol & Sugar Free
Compares to Children's Benadryl ® Allergy.
4 FL. OZ.
(118 mL) NDC 45014-140-04
diphenhydramine hydrochloride liquid
HUMAN OTC DRUG
Item Code (Source)
Route of Administration
Active Ingredient/Active Moiety
Basis of Strength
12.5 mg in 5 mL
Citric Acid Monohydrate
D&C RED NO. 33
FD&C RED NO. 40
118 mL in 1 BOTTLE
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
OTC MONOGRAPH FINAL
Labeler - Accudial Pharmaceutical, Inc.
Revised: 11/2009 Accudial Pharmaceutical, Inc.