Drug Facts
01e7dddb-755c-4745-b701-edcdb6209064
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
- temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Purposes
Pain reliever
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 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Directions
- do not take more than directed(see overdose warning)
- adults and children 12 years of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor
- do not give to children under 12 years of age
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 are allergic to acetaminophen or any of the inactive ingredients in 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.
Other Information
- store below 25°C (77°F)
Overdose Warning:
Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Inactive Ingredients
carnauba wax, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide
Questions Or Comments?
1-800-455-7139
Principal Display Panel
NDC 0135-0608-01
PANADOL
EXTRA STRENGTH
PM
ACETAMNOPHEN
Pain Reliever
DIPHENHYDRAMINE HCl
Nighttime Sleep-Aid
24 CAPLETS
Tamper-Evident Feature:Do not use if printed bottle seal (under cap) is missing or broken.
READ AND KEEP CARTON FOR COMPLETE INFORMATION
Trademarks are owned by or licensed to the GSK group of companies.
Distributed by:
GSKConsumer Healthcare, Warren, NJ 07059
©2016 GSK group of companies or its licensor.
101639XE
When Using This Product
- drowsiness will occur
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- any new symptoms appear
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 HCl 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
- 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
Warnings
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
Directions
- do not take more than directed(see overdose warning)
- adults and children 12 years of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor
- do not give to children under 12 years of age
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 are allergic to acetaminophen or any of the inactive ingredients in this product
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.
Other Information (Other information)
- store below 25°C (77°F)
Overdose Warning: (Overdose warning:)
Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Inactive Ingredients (Inactive ingredients)
carnauba wax, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide
Questions Or Comments? (Questions or comments?)
1-800-455-7139
Principal Display Panel
NDC 0135-0608-01
PANADOL
EXTRA STRENGTH
PM
ACETAMNOPHEN
Pain Reliever
DIPHENHYDRAMINE HCl
Nighttime Sleep-Aid
24 CAPLETS
Tamper-Evident Feature:Do not use if printed bottle seal (under cap) is missing or broken.
READ AND KEEP CARTON FOR COMPLETE INFORMATION
Trademarks are owned by or licensed to the GSK group of companies.
Distributed by:
GSKConsumer Healthcare, Warren, NJ 07059
©2016 GSK group of companies or its licensor.
101639XE
When Using This Product (When using this product)
- drowsiness will occur
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating 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 a serious underlying medical illness.
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- any new symptoms appear
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 HCl 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 Taking (Ask a doctor or pharmacist before use if you are taking)
- the blood thinning drug warfarin
- sedatives or tranquilizers
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:02:46.035067 · Updated: 2026-03-14T23:02:29.359860