Allergy

Accudial Pharmaceutical, Inc.

Dosage Form

N/A

Manufacturer

Accudial Pharmaceutical, Inc.

Important Safety Information

This medication contains important usage instructions, warnings, and side effect information that you should review before use.

Full label on DailyMed PDF Full label (ZIP)

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

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

What it looks like

Photos of the product and/or packaging supplied by the manufacturer.

Package codes (NDC)

45014-161-04

Full prescribing information (for healthcare professionals)

SPL UNCLASSIFIED SECTION

Drug Facts

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.

SPL UNCLASSIFIED SECTION

Distributed by: AccuDial® Pharmaceutical, Inc. Palm Beach Gardens, FL 33408

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Important Safety Information

What this medicine is forThe uses this medicine is approved for.

What this medicine is forOver-the-counter use.

How to take itDosage and administration instructions.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.

Do not use if…Keep out of reach of children.

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

Ask a doctor or pharmacist before use if…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 deliv…

Stop use and talk to a doctor if…to make a child sleepy with any other product containing diphenhydramine, even one used on skin

Storage and handlingeach 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.

Package labelACCUDIAL ® 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 Compare…

What it looks like

Package codes (NDC)

SPL UNCLASSIFIED SECTION

Overdose warning

SPL UNCLASSIFIED SECTION

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