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Acetaminophen and Diphenhydramine Hcl

OTC Oral RxCUI 1092189
Contents

Overview

Active ingredient
Diphenhydramine, Acetaminophen
Established class
Histamine-1 Receptor Antagonist
Mechanism class
Histamine H1 Receptor Antagonists
Route
Oral
Label date
2025-12-19

Indications and usage

Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Purpose

Pain reliever Nighttime sleep aid

Dosage and administration

Directions

  • do not take more than directed (see overdose warning) adults and children 12 years and over
  • take 2 caplets at bedtime
  • do not take more than 2 caplets of this product in 24 hours children under 12 years
  • do not use

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 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
  • in children under 12 years of age
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

Ask a doctor before use if you have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

this product

  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

and ask a doctor if

  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur These could be signs of a serious condition

Overdosage

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Pregnancy or breast-feeding

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

Active ingredient (label)

s (in each caplet) Acetaminophen USP, 500 mg Diphenhydramine HCl USP, 25 mg

Inactive ingredients

s carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k-30, pregelatinized starch, stearic acid, titanium dioxide

Storage and handling

Other information

  • store between 20-25°C (68-77°F). See USP Controlled Room Temperature.
  • see end panel for lot number and expiration date

Keep out of reach of children

of children Keep out of reach of children