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
Theraflu Flu Relief Max Strength
- Manufacturer
- Haleon US Holdings LLC
- Effective date
- 2025-05-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:01:09
Label at a glance#
ProductTheraflu Flu Relief Max Strength Nighttime
Active ingredientACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections
Dosage and administration
do not use more than directed take every 6 hours, while symptoms persist. Do not take more than 3 packets in 24 hours unless directed by a doctor. Age Dose adults and children 12 years of age and over one packet children under 12 years of age do not use dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. if using a microwave, add contents of one packet to...
Contacts and useful links#
Websitewww.stopmedicineabuse.org
www.StopMedicineAbuse.org
www.StopMedicineAbuse.orgLabel contents#
Full prescribing information#
Active ingredients (in each packet)
Acetaminophen 1000 mg
Chlorpheniramine maleate 4 mg
Dextromethorphan HBr 30 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
- take every 6 hours, while symptoms persist. Do not take more than 3 packets in 24 hours unless directed by a doctor.
Age | Dose |
adults and children 12 years of age and over | one packet |
children under 12 years of age | do not use |
- dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
- if using a microwave, add contents of one packet to 8 oz of cool water; stir briskly before and after heating. Do not overheat.
Other information
- each packet contains:potassium 5 mg, sodium 22 mg
- phenylketonurics:contains phenylalanine 12.9 mg per packet
- store at a controlled room temperature at 20 – 25°C (68 – 77°F)
Inactive ingredients
acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, maltodextrin, natural and artificial flavors, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate
Questions or comments?
1-855-297-3031
Additional Information
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD.
HOT LIQUID THERAPYthat relieves:
Fever
Body Ache
Headache
Sore Throat Pain
Cough
Runny Nose
Honey Lemon Flavor
*Maximum Strength per 6 hour dose
**Temporarily controls cough to help you rest. This is not a sleep-aid.
PARENTS:Learn about teen medicine abuse
TAMPER EVIDENT INNER UNIT DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN
1-855-297-3031
Distributed by: Haleon, Warren, NJ 07069
Trademarks are owned by or licensed to the
Haleon group of companies.
©2025 Haleon group of companies or its licensor.
62000000217489
Principal Display Panel
MULTI-SYMPTOM FLU RELIEF
HALEON
THERAFLU
FLU RELIEF MAX STRENGTH*
NIGHTTIME
Acetaminophen
Pain Reliever/Fever Reducer
Chlorpheniramine Maleate
Antihistamine
Dextromethorphan HBr
Cough Suppressant
HELPS YOU REST**
Hot liquid therapythat relieves:
/ Fever
/ Body ache
/ Headache
/ Sore throat pain
/ Cough
/ Runny nose
Honey Lemon Flavor
6 PACKETS
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2636658 | acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG Powder for Oral Solution | PSN | 2 |
| 2636658 | acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution | SCD | 2 |
| 2636658 | acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Granules for Oral Solution | SY | 2 |
| 2636658 | APAP 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution | 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 |
|---|---|---|---|---|---|---|
| 0067-7922-02 | Theraflu Flu Relief Max StrengthNighttime | 6 in 1 CARTON | POWDER | 6 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0067-7922 | THERAFLU FLU RELIEF MAX STRENGTH NIGHTTIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) POWDER [HALEON US HOLDINGS LLC] | 2 | Current NDC, 1 package rows | 20250519_51c7628a-c7cf-498f-8fb1-db732e2b8b6e.zip |
Products#
Every source-derived product name is available through these pages.
- Theraflu Flu Relief Max Strength Nighttime
- Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr
- ACESULFAME POTASSIUM
- ANHYDROUS CITRIC ACID
- ASPARTAME
- D&C YELLOW NO. 10
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- MALTODEXTRIN
- SILICON DIOXIDE
- SODIUM CITRATE, UNSPECIFIED FORM
- SOYBEAN LECITHIN
- SUCROSE
- TRIBASIC CALCIUM PHOSPHATE
- ACETAMINOPHEN
- CHLORPHENIRAMINE MALEATE
- CHLORPHENIRAMINE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0067-7922 | 0067-7922-02 |
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 |
|---|---|---|---|---|---|---|
| Theraflu Flu Relief Max Strength Daytime Nighttime Combo Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 812a093f-cf83-4f7a-927a-1b5695be7f90 | 2025-05-19 | Warnings | 0067-7922-02 00067792202 |
| Theraflu Flu Relief Max Strength Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 51c7628a-c7cf-498f-8fb1-db732e2b8b6e | 2025-05-16 | Warnings | 0067-7922-02 0067-7922 00067792202 3542d501-f30f-6043-e063-6394a90ac050 51c7628a-c7cf-498f-8fb1-db732e2b8b6e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.