Active Ingredients (In Each Caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Panadol Tablet, Film Coated
FDA Label NDC 0135-7021
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Panadol (NDC 0135-7021). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each caplet), purposes, uses, warnings, allergy alert:, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are taking, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Pain reliever
Nighttime sleep-aid
Uses
- temporary relief of 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 4,000 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 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 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
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
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.
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.
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
Other Information
- store at 25°C (77°F)
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, FD&C blue no. 1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, stearic acid, talc, titanium dioxide
Questions?
1-800-455-7139
Principal Display Panel
NDC 0135-7021-01
Panadol
EXTRA STRENGTH
PM
ACETAMNOPHEN
Pain Reliever
DIPHENHYDRAMINE HCl
Nighttime Sleep-Aid
2 CAPLETS
TAMPER EVIDENT FEATURE: DO NOT USE IF PACKET IS DAMAGED OR OPEN
Fold Back And Tear To Open Or Use Scissors
Distributed by:
GSKConsumer Healthcare, Warren, NJ 07059
Trademarks owned or licensed by GSK.
©2021 GSK or licensor.
TR-0630-765-24 ORG
Tr-0630-765-24 Panadol Pm 2 Ct (Image 01)
* Please review the disclaimer below.
