Pain Releiver Pm
d92d97a8-0ee3-1206-e053-2a95a90a72a8
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen USP, 500mg Diphenhydramine HCL USP,25mg
Purpose
Pain reliever Nighttime sleep aid
Medication Information
Purpose
Pain reliever Nighttime sleep aid
Description
Acetaminophen USP, 500mg Diphenhydramine HCL USP,25mg
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Purposes
Pain reliever
Nighttime sleep aid
Directions
■ do not take more than directed (see overdose warning)
adults and children 12 years and over
■ take 2 gelcaps at bedtime
■ do not take more than 2 gelcaps 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
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.
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
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.
Other Information
■ store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature.
■ see bottom of the label for expiration date and lot number.
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, D&C red#28, D&C yellow#10, FD&C blue#1, FD&C blue #2, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, microcrystalline cellulose, n-butyl alcohol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, triacetin.
Questions Or Comments?
call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.
Principal Display Panel
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.
Keep Out of Reach of Children
Keep out of reach of children
If Pregnant Or Breast Feeding,
ask a health professional before use.
Active Ingredients (in Each Gelcap)
Acetaminophen USP, 500mg
Diphenhydramine HCL USP,25mg
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
Structured Label Content
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Purposes
Pain reliever
Nighttime sleep aid
Directions
■ do not take more than directed (see overdose warning)
adults and children 12 years and over
■ take 2 gelcaps at bedtime
■ do not take more than 2 gelcaps 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
Allergy Alert (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.
Liver Warning (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
Overdose Warning (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.
Other Information (Other information)
■ store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature.
■ see bottom of the label for expiration date and lot number.
Inactive Ingredients (Inactive ingredients)
colloidal silicon dioxide, croscarmellose sodium, D&C red#28, D&C yellow#10, FD&C blue#1, FD&C blue #2, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, microcrystalline cellulose, n-butyl alcohol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, triacetin.
Questions Or Comments? (Questions or comments?)
call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.
Principal Display Panel
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.
Keep Out of Reach of Children (Keep out of reach of children)
Keep out of reach of children
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)
ask a health professional before use.
Active Ingredients (in Each Gelcap) (Active ingredients (in each gelcap))
Acetaminophen USP, 500mg
Diphenhydramine HCL USP,25mg
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 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: 2026-02-15T12:07:49.958634 · Updated: 2026-03-14T23:11:42.520832