Indications and uses
temporarily relieves these symptoms due to a common cold or flu: headache minor aches and pains cough due to minor throat and bronchial irritation minor sore throat pain runny nose temporarily reduces fever
Panadol Cold and Flu Night - Haleon US Holdings LLC
- Manufacturer
- Haleon US Holdings LLC
- Effective date
- 2026-04-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:55:15
Label at a glance#
ProductPanadol Cold and Flu Night
Active ingredientACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections
Dosage and administration
do not use more than directed adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist do not take more than 6 caplets in 24 hours unless directed by a doctor children under 12 years of age: do not use Age Dose adults and children 12 years of age and over 2 caplets every 6 hours children under 12 years of age do not use
Contacts and useful links#
Websitewww.stopmedicineabuse.org
www.StopMedicineAbuse.org
www.StopMedicineAbuse.orgLabel contents#
Full prescribing information#
Active ingredients (in each caplet)
Acetaminophen 500 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 15 mg
Purposes
Pain reliever/Fever reducer
Antihistamine
Cough suppressant
Uses
- temporarily relieves these symptoms due to a common cold or flu:
- headache
- minor aches and pains
- cough due to minor throat and bronchial irritation
- minor sore throat pain
- runny nose
- temporarily reduces fever
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.
Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.
Do not use
- in a child under 12 years of age
- if you are allergic to acetaminophen
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- avoid alcoholic drinks
- marked drowsiness may occur
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Stop use and ask a doctor if
- pain or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts
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.
In case of 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.
Directions
- do not use more than directed
- adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist
- do not take more than 6 caplets in 24 hours unless directed by a doctor
- children under 12 years of age: do not use
Age | Dose |
adults and children 12 years of age and over | 2 caplets every 6 hours |
children under 12 years of age | do not use |
Other information
- store at a controlled room temperature 20-25°C (68-77°F)
Inactive ingredients
crospovidone, FD&C blue no. 2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
Questionsor comments?
1-855-297-3031
Additional Information
Do not use if blister is broken or damaged.
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD.
PARENTS: Learn about teen medicine abuse
www.StopMedicineAbuse.org
Package/Label Principal Display Panel
NEW
Cold& Flu
Panadol
Night
Acetaminophen
Pain Reliever/Fever Reducer ✓
Chlorpheniramine Maleate
Antihistamine ✓
Dextromethorphan HBr
Cough Suppressant ✓
20 Caplets
Actual Size
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1098496 | acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG Oral Tablet | PSN | 2 |
| 1098496 | acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral Tablet | SCD | 2 |
| 1098496 | APAP 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral Tablet | SY | 2 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CHLORPHENIRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0135-7034-20 | PanadolCold and Flu Night | 10 in 1 BLISTER PACK | TABLET | 10 | 2 | |
| 0135-7034-20 | PanadolCold and Flu Night | 2 in 1 CARTON | TABLET | 2 | 2 |
Products#
Every source-derived product name is available through these pages.
- Panadol Cold and Flu Night
- acetaminophen, chlorpheniramine maleate, dextromethorphan HBr
- CROSPOVIDONE, UNSPECIFIED
- FD&C BLUE NO. 2 ALUMINUM LAKE
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYVINYL ALCOHOL, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- STARCH, CORN
- SILICON DIOXIDE
- SODIUM STARCH GLYCOLATE TYPE A
- STEARIC ACID
- TALC
- TITANIUM DIOXIDE
- ACETAMINOPHEN
- CHLORPHENIRAMINE MALEATE
- CHLORPHENIRAMINE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0135-7034 | 0135-7034-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Panadol Cold and Flu Night | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 3417993d-8e3c-23d6-e063-6394a90a7d50 | 2026-04-29 | Warnings | 0135-7034-20 0135-7034 00135703420 509e32fe-7608-69c1-e063-6394a90a0dc0 3417993d-8e3c-23d6-e063-6394a90a7d50 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.