Drug Facts
91ba1618-1b2e-4281-a5e1-ba7acbae8346
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 500 mg Diphenhydramine HCl 25 mg
Purpose
Pain reliever Nighttime sleep aid
Medication Information
Purpose
Pain reliever
Nighttime sleep aid
Description
Acetaminophen 500 mg Diphenhydramine HCl 25 mg
Uses
temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 4000 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 sever skin reactions.
Symptoms may include: ■ skin reddening ■ blisters ■ rash
If a skin reaction occurs, stop use and seek medical help right away.
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
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
Inactive Ingredients
croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glylcol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide
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.
- You may report side effects to 1-888-952-0050
Keep Out of Reach of Children
Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
If Pregnant Or Breast Feeding,
If pregnant or breast-feeding, ask a health professional before use.
Active Ingredients (in Each Caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
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 If You Are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
Package/label Principal Display Panel
Health A2Z® Compare to Tylenol® PM active ingredient*
See New Warnings Information
Extra Strength
Pain Reliever/Sleep Aid
PAIN RELIEF PM
Acetaminophen 500mg
Diphenhydramine HCl 25mg
Caplets
Structured Label Content
Uses
temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness
Purpose
Pain reliever
Nighttime sleep aid
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 4000 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 sever skin reactions.
Symptoms may include: ■ skin reddening ■ blisters ■ rash
If a skin reaction occurs, stop use and seek medical help right away.
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
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
Inactive Ingredients
croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glylcol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide
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.
- You may report side effects to 1-888-952-0050
Keep Out of Reach of Children (Keep out of reach of children)
Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
If Pregnant Or Breast Feeding, (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 HCl 25 mg
Ask A Doctor Before Use If You Have (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 If You Are (Ask a doctor or pharmacist if you are)
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
Package/label Principal Display Panel (Package/Label Principal Display Panel)
Health A2Z® Compare to Tylenol® PM active ingredient*
See New Warnings Information
Extra Strength
Pain Reliever/Sleep Aid
PAIN RELIEF PM
Acetaminophen 500mg
Diphenhydramine HCl 25mg
Caplets
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:56:43.316655 · Updated: 2026-03-14T22:55:23.037919