Pain Relief Pm
32a5611b-9bf6-4850-a7ff-fa240da04f45
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 500 mg Diphenhydramine 25 mg
Purpose
Acetaminophen 500 mg ....................................................................................................................................Pain reliever Diphenhydramine HCl 25 mg ...........................................................................….................................Nighttime sleep aid
Medication Information
Purpose
Acetaminophen 500 mg ....................................................................................................................................Pain reliever
Diphenhydramine HCl 25 mg ...........................................................................….................................Nighttime sleep aid
Description
Acetaminophen 500 mg Diphenhydramine 25 mg
Uses:
- temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Section 50565-1
KEEP OUT OF REACH OF CHILDREN
Overdose warning:
In case of overdose, get medical help or contact Poison Control (1-800-222-1222) right away.
Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Section 51945-4
Warnings:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 4,000 mg of acetaminophen in 24 hrs ■ 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.
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 in 24 hours unless directed by a doctor
■ children under 12 years do not use
Other Information:
- store at 20°-25°C (68°-77°F)
Inactive Ingredients:
FD & C Blue # 1, FD & C Blue # 2, Hypromellose, Microcrystalline Cellulose, Magnesium Stearate, Polyethylene glycol 400, Pregelatinized Starch, Polyvinyl Pyrrolidone, Stearic Acid Powder, Titanium Dioxide.
Questions Or Comments?
Call 1-718-337-8733 or visit [email protected]
When Using This Product
■ drowsiness will occur
■ avoid alcoholic drinks
■ do not drive a motor vehicle or operate machinery.
Stop Use 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.
If Pregnant Or Breast Feeding
ask a health professional before use.
Active Ingredients (in Each Caplet)
Acetaminophen 500 mg
Diphenhydramine 25 mg
Ask A Doctor Before Use If You Have:
■ liver disease
■ glaucoma
■ a breathing problem such as emphysema or chronic bronchitis
■ trouble urinating due to an enlarged prostate gland.
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
Structured Label Content
Uses:
- temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Section 50565-1 (50565-1)
KEEP OUT OF REACH OF CHILDREN
Overdose warning:
In case of overdose, get medical help or contact Poison Control (1-800-222-1222) right away.
Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Section 51945-4 (51945-4)
Purpose
Acetaminophen 500 mg ....................................................................................................................................Pain reliever
Diphenhydramine HCl 25 mg ...........................................................................….................................Nighttime sleep aid
Warnings:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 4,000 mg of acetaminophen in 24 hrs ■ 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 (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.
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 in 24 hours unless directed by a doctor
■ children under 12 years do not use
Other Information:
- store at 20°-25°C (68°-77°F)
Inactive Ingredients:
FD & C Blue # 1, FD & C Blue # 2, Hypromellose, Microcrystalline Cellulose, Magnesium Stearate, Polyethylene glycol 400, Pregelatinized Starch, Polyvinyl Pyrrolidone, Stearic Acid Powder, Titanium Dioxide.
Questions Or Comments? (Questions or Comments?)
Call 1-718-337-8733 or visit [email protected]
When Using This Product (When using this product)
■ drowsiness will occur
■ avoid alcoholic drinks
■ do not drive a motor vehicle or operate machinery.
Stop Use and Ask A Doctor If (Stop use 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.
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)
ask a health professional before use.
Active Ingredients (in Each Caplet) (Active Ingredients (in each caplet))
Acetaminophen 500 mg
Diphenhydramine 25 mg
Ask A Doctor Before Use If You Have: (Ask a doctor before use if you have:)
■ liver disease
■ glaucoma
■ a breathing problem such as emphysema or chronic bronchitis
■ trouble urinating due to an enlarged prostate gland.
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are )
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:49.065674 · Updated: 2026-03-14T23:11:40.308391