PANADOL PM
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- PANADOL PM
- Generic name
- ACETAMINOPHEN AND DIPHENHYDRAMINE HCL
- Manufacturer
- Haleon US Holdings LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 01e7dddb-755c-4745-b701-edcdb6209064
- SPL ID
- 10c16df6-aa2f-03c3-e063-6294a90a93e5
- Version
- 7
- Effective date
- 2024-02-06
- Source export date
- 2026-09-28
- Source partition
- 8
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:52:50
| Harmonized routes |
|---|
| ORAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application number | M013 | openfda.application_number | |
| brand name | PANADOL PM | openfda.brand_name | |
| generic name | ACETAMINOPHEN AND DIPHENHYDRAMINE HCL | openfda.generic_name | |
| manufacturer name | Haleon US Holdings LLC | openfda.manufacturer_name | |
| ndc | package | 0135-0608-01 | openfda.package_ndc |
| ndc | package | 0135-0608-04 | openfda.package_ndc |
| ndc | package | 0135-0608-03 | openfda.package_ndc |
| ndc | package | 0135-0608-02 | openfda.package_ndc |
| ndc | product | 0135-0608 | openfda.product_ndc |
| ndc11 | package | 00135060803 | derived:openfda.package_ndc |
| ndc11 | package | 00135060802 | derived:openfda.package_ndc |
| ndc11 | package | 00135060804 | derived:openfda.package_ndc |
| ndc11 | package | 00135060801 | derived:openfda.package_ndc |
| rxcui | 1092189 | openfda.rxcui | |
| rxcui | 1094718 | openfda.rxcui | |
| spl id | 10c16df6-aa2f-03c3-e063-6294a90a93e5 | id | |
| spl set id | 01e7dddb-755c-4745-b701-edcdb6209064 | set_id | |
| unii | TC2D6JAD40 | openfda.unii | |
| unii | 362O9ITL9D | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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. Keep out of reach of children. 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.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.