Pain Relief Pm
0181af13-da32-4431-be39-c31fdfac9202
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 42229-5
This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare
Division., owner of the registered trademark Tylenol® Extra Strength Tablets.
Distributed by: GenCare Consumer Products, LLC 40E Cotters Ln Suite A, East Brunswick, NJ 08816
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)
- do not use if foil or inner seal is broken or missing
Inactive Ingredients:
Croscarmellose Sodium, FD & C Blue#1 Aluminium Lake, FD &C Blue#2
Aluminium Lake, Hypromelloses, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene
Glycol, Polyvinyl Alcohol, Povidone K30, Purified Water, Silicon Dioxide, Sodium Starch Glycolate,
Starch Corn, Talc, Titanium Dioxide.
Questions Or Comments?
Call 1-732-698-5070 Monday through Friday 9am to 5pm EST or visit www.pioneerlifesciences.com
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 42229-5 (42229-5)
This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare
Division., owner of the registered trademark Tylenol® Extra Strength Tablets.
Distributed by: GenCare Consumer Products, LLC 40E Cotters Ln Suite A, East Brunswick, NJ 08816
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)
- do not use if foil or inner seal is broken or missing
Inactive Ingredients:
Croscarmellose Sodium, FD & C Blue#1 Aluminium Lake, FD &C Blue#2
Aluminium Lake, Hypromelloses, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene
Glycol, Polyvinyl Alcohol, Povidone K30, Purified Water, Silicon Dioxide, Sodium Starch Glycolate,
Starch Corn, Talc, Titanium Dioxide.
Questions Or Comments? (Questions or Comments?)
Call 1-732-698-5070 Monday through Friday 9am to 5pm EST or visit www.pioneerlifesciences.com
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: 2026-02-15T12:07:55.740278 · Updated: 2026-03-14T23:11:56.566307