pain relief pm - extra strength
9238598b-1202-921f-e053-2995a90a019f
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 500mg; Diphenhydramine 25mg
Medication Information
Warnings and Precautions
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4000mg 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 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 non prescription). 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 youhave ever 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 prostrate gland
- glaucoma
Ask a doctor or a pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- drowsiness will occur
- avoi 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
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition
If pregnant or breast-feeding,
ask a health professional before use
Keep out of reach of children
Overdose warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Active Ingredient
Acetaminophen 500mg; Diphenhydramine 25mg
Indications and Usage
*temporarily relief of occasional heaches and minor aches and pains with accompanying sleeplessness
Dosage and Administration
- take with a full glass of water
- do not take more than directed
- do not take more than 2 caplets in 24 hours
| adults and children 12 years of age and over |
|
| children under 12 years of age | do not use |
Description
Acetaminophen 500mg; Diphenhydramine 25mg
Section 50565-1
Keep out of reach of children
Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Section 51727-6
colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, hydroxypropyl methyl cellulose, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide
Section 51945-4
Section 55105-1
Pain reliever
Nighttime sleep-aid
Section 60561-8
- store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)
Structured Label Content
Warnings and Precautions (34071-1)
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4000mg 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 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 non prescription). 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 youhave ever 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 prostrate gland
- glaucoma
Ask a doctor or a pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- drowsiness will occur
- avoi 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
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition
If pregnant or breast-feeding,
ask a health professional before use
Keep out of reach of children
Overdose warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Active Ingredient (55106-9)
Acetaminophen 500mg; Diphenhydramine 25mg
Indications and Usage (34067-9)
*temporarily relief of occasional heaches and minor aches and pains with accompanying sleeplessness
Dosage and Administration (34068-7)
- take with a full glass of water
- do not take more than directed
- do not take more than 2 caplets in 24 hours
| adults and children 12 years of age and over |
|
| children under 12 years of age | do not use |
Section 50565-1 (50565-1)
Keep out of reach of children
Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Section 51727-6 (51727-6)
colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, hydroxypropyl methyl cellulose, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide
Section 51945-4 (51945-4)
Section 55105-1 (55105-1)
Pain reliever
Nighttime sleep-aid
Section 60561-8 (60561-8)
- store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T11:59:03.230366 · Updated: 2026-03-14T22:58:52.562418