Drug Facts
499b2bf8-72fb-4500-b16e-517cab09a8ae
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 500mg Diphenhydramine HCl 25mg
Purpose
Pain reliever Nightime sleep aid
Medication Information
Purpose
Pain reliever
Nightime sleep aid
Description
Acetaminophen 500mg Diphenhydramine HCl 25mg
Uses
Temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness
Section 51945-4
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.
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 even had an allergic reaction to this product or any of its ingredients
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 you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
•drowsiness will occur
•do not drive a motor vehicle or operate machinery
•avoid alcoholic drinks
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 last for more than 10 days.
•fever gets worse or last for more than 3 days
•redness or swelling are present
•new symptoms occur. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Directions
Do not use more than directed. (see overdose warning)
Adults and children 12 years of age and older:Take 2 caplets at bedtime. Do not take more than 2 caplets in 24 hours
Children under 12 years:do not use
Active Ingredients
Acetaminophen 500mg
Diphenhydramine HCl 25mg
Inactive Ingredients
Croscarmellose sodium, FD and C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, starch, stearic acid, titanium dioxide, Copovidone K25-31, Lactose, and Magnesium Sterate
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. Quick Medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Structured Label Content
Uses
Temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness
Section 51945-4 (51945-4)
Purpose
Pain reliever
Nightime 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.
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 even had an allergic reaction to this product or any of its ingredients
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 you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
•drowsiness will occur
•do not drive a motor vehicle or operate machinery
•avoid alcoholic drinks
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 last for more than 10 days.
•fever gets worse or last for more than 3 days
•redness or swelling are present
•new symptoms occur. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Directions
Do not use more than directed. (see overdose warning)
Adults and children 12 years of age and older:Take 2 caplets at bedtime. Do not take more than 2 caplets in 24 hours
Children under 12 years:do not use
Active Ingredients
Acetaminophen 500mg
Diphenhydramine HCl 25mg
Inactive Ingredients
Croscarmellose sodium, FD and C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, starch, stearic acid, titanium dioxide, Copovidone K25-31, Lactose, and Magnesium Sterate
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. Quick Medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Advanced Ingredient Data
Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:51.511861 · Updated: 2026-03-14T23:11:47.306350