pilldic.Your medicine dictionary
Text size
← US medicines
US · Over-the-counter medicine

Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride

Dosage form
TABLET, FILM COATED
Labeler
HHH Pharmaceuticals
Label updated
2026-06-26
Retrieved
2026-09-07
Active ingredients
ACETAMINOPHEN · DIPHENHYDRAMINE HYDROCHLORIDE
View original label and images on DailyMed ↗
Label information

Drug Facts

Active Ingredients

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Antihistamine

Nasal decongestant

Uses
  • temporarily relieves these symptoms of hay fever and the common cold:
  • runny nose
  • sneezing
  • headache
  • minor aches and pains
  • nasal congestion
  • temporarily relieves these additional symptoms of hay fever:
  • itching of the nose or throat
  • itchy, watery eyes
Warnings

Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product


Allergy alert:Acetaminophen may cause severe skin reactions.

Symptoms may include:

  • skin reddening 
  • blisters 
  • rash 
  • hives
  • facial swelling 
  • asthma (wheezing) 
  • shock

If a skin reaction occurs, stop use and seek medical help right away.


Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • with any other product containing diphenhydramine, even one used on skin
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • if you have ever had an allergic reaction to this product or any of its ingredients acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if you have
  • liver disease
  • glaucoma 
  • thyroid disease 
  • heart disease
  • diabetes 
  • high blood pressure 
  • difficulty in urination due to enlargement of the prostate gland 
  • a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
When using this product
  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery 
  • avoid alcoholic beverages
Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
Label information

If pregnant or breast-feeding, ask a health professional before use.

Label information

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
  • do not use more than directed
  • adults and children 12 years and over: take 2 caplets every 4 hours
  • do not take more than 10 caplets in 24 hours
  • children under 12 years: ask a doctor
Other information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
Inactive ingredients

microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, polyvinyl pyrrolidone K 30, colloidal silicon dioxide, stearic acid powder, polyvinyl alcohol, talc, titanium dioxide

Questions or comments?

Call + 1-848-235-5293

Monday through Friday 9AM – 4PM EST

PRINCIPAL DISPLAY PANEL

[Image in the official label — see DailyMed source]

DailyMed Set ID: 265f1ce7-160c-4dda-b2e0-b78d68f962bd · Version 1
NDC: 83586-004