Indications and uses
• temporarily relieves these symptoms due to a cold: • minor aches and pains • minor sore throat pain • headache • cough due to minor throat and bronchial irritation • temporarily reduces fever
Theraflu
- Manufacturer
- Haleon US Holdings LLC
- Effective date
- 2024-04-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:11:03
Label at a glance#
ProductTheraflu Severe Cold Relief Combo Pack
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure18 sections
Dosage and administration
• do not use more than directed • take every 4 hours, while symptoms persist. Do not take more than 6 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 p...
Contacts and useful links#
Websitewww.stopmedicineabuse.org
www.StopMedicineAbuse.org
www.StopMedicineAbuse.orgWebsitewww.productpats.com
www.productpats.com
www.productpats.comLabel contents#
Full prescribing information#
Active Ingredients (in each packet) (Daytime)
Acetaminophen 500 mg
Dextromethorphan HBr 20 mg
Purposes (Daytime)
Pain reliever/Fever reducer
Cough suppressant
Active ingredients (in each packet) (Nighttime)
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
Purposes (Nighttime)
Pain reliever/Fever reducer
Antihistamine/Cough suppressant
Uses (Daytime)
• temporarily relieves these symptoms due to a cold:
- • minor aches and pains • minor sore throat pain • headache
- • cough due to minor throat and bronchial irritation
• temporarily reduces fever
Uses (Nighttime)
• temporarily relieves these symptoms due to a cold:
- • minor aches and pains • minor sore throat pain
- • headache • runny nose
- • sneezing • itchy nose or throat
- • itchy, watery eyes due to hay fever
- • cough due to minor throat and bronchial irritation
• temporarily reduces fever
Warnings (Daytime)
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
• 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
Stop use and ask a doctor if
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• pain or cough gets worse or lasts more than 7 days
• 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.
Warnings (Nighttime)
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.
• with any other product containing diphenhydramine, even one used on the skin
• 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 • glaucoma
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis
• 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 sedatives or tranquilizers
• taking the blood thinning drug warfarin
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
• 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
• pain or cough gets worse or lasts more than 7 days
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 (Daytime)
• do not use more than directed
• take every 4 hours, while symptoms persist. Do not take more than 6 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.
Directions (Nighttime)
• do not use more than directed
• take every 4 hours, while symptoms persist. Do not take more than 5 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 (Daytime)
• each packet contains: potassium 10 mg, sodium 20 mg
• phenylketonurics: contains phenylalanine 20 mg per packet
• store at controlled room temperature 20-25°C (68-77°F). Protect product from heat and moisture.
Other information (Nighttime)
• each packet contains: potassium 10 mg, sodium 23 mg
• phenylketonurics: contains phenylalanine 13 mg per packet
• store at controlled room temperature 20-25°C (68-77°F). Protect product from heat and moisture.
Inactive ingredients (Daytime)
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
Inactive Ingredients (Nighttime)
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? (Daytime)
1-855-328-5259
Questions or comments? (Nighttime)
1-855-328-5259
Other Information
DO NOT TAKE THE THERAFLU SEVERE COLD RELIEF DAYTIME AND THERAFLU
SEVERE COLD RELIEF NIGHTTIME PRODUCTS AT THE SAME TIME.
DO NOT TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.
PARENTS:
Learn about teen medicine abusewww.StopMedicineAbuse.org
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.
KEEP CARTON FOR REFERENCE. DO NOT DISCARD.
DO NOT TAKE THE THERAFLU SEVERE COLD RELIEF DAYTIME AND THERAFLU
SEVERE COLD RELIEF NIGHTTIME PRODUCTS AT THE SAME TIME.
DO NOT TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.
DO NOT TAKE A DOSE OF THE SEVERE COLD RELIEF NIGHTTIME PRODUCT
SOONER THAN 4 HOURS AFTER THE LAST DOSE OF SEVERE COLD RELIEF
DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.
TAMPER EVIDENT INNER UNIT
DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN
1-855-328-5259
Distributed by: Haleon, Warren, NJ 07059
©2023 Haleon group of companies or its licensor.
Trademarks are owned by or licensed to the Haleon group of companies.
Pat. Info www.productpats.com
207734
Package/Label Principal Display Panel
MULTI-SYMPTOM COLD RELIEF
NEW FORMULA
THERAFLU
SEVERE
COLD RELIEF
COMBO PACK
6 x DAYTIME
Acetaminophen Pain Reliever/Fever Reducer
Dextromethorphan HBr Cough Suppressant
6 x NIGHTTIME
Acetaminophen Pain reliever/Fever Reducer
Diphenhydramine HCl Antihistamine/Cough Suppressant
Hot liquid therapy that relieves:
/ Cough / Sore throat pain
/ Head and body ache / Fever
/ Runny nose (Nighttime only)
/ Sneezing (Nighttime only)
6 DAYTIME PACKETS
6 NIGHTTIME PACKETS
12 TOTAL PACKETS
Honey Lemon Flavor
USE AS DIRECTED
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2679426 | {1 (acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral Solution) / 1 (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Granules for Oral Solution) } Pack | GPCK | 1 |
| 2679426 | 1 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG Granules for Oral Solution) Pack | PSN | 1 |
| 2679420 | acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral Solution | PSN | 1 |
| 2670598 | acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution | PSN | 1 |
| 2670677 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG Powder for Oral Solution | PSN | 1 |
| 2679425 | acetaminophen 650 MG / diphenhydrAMINE hydrochloride 25 MG Granules for Oral Solution | PSN | 1 |
| 2679420 | acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral Solution | SCD | 1 |
| 2670598 | acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution | SCD | 1 |
| 2679425 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Granules for Oral Solution | SCD | 1 |
| 2670677 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral Solution | SCD | 1 |
| 2679426 | {1 (acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution) / 1 (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral Solution) } Pack | SY | 1 |
| 2679426 | 1 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydramine HCl 25 MG Granules for Oral Solution) Pack | SY | 1 |
| 2670677 | acetaminophen 650 MG / diphenhydramine HCl 25 MG Granules for Oral Solution | SY | 1 |
| 2670677 | acetaminophen 650 MG / diphenhydramine HCl 25 MG Packet for Oral Solution | SY | 1 |
| 2679420 | APAP 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral Solution | SY | 1 |
| 2670598 | APAP 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution | SY | 1 |
| 2679425 | APAP 650 MG / diphenhydramine hydrochloride 25 MG Granules for Oral Solution | SY | 1 |
| 2670677 | APAP 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral Solution | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0067-0100-06 | TherafluSevere Cold Relief Combo Pack | 1 in 1 PACKET | POWDER, FOR SOLUTION | 1 | 500 mg | 1 |
| 0067-0100-06 | TherafluSevere Cold Relief Combo Pack | 6 in 1 CARTON | POWDER, FOR SOLUTION | 20 mg | 1 | |
| 0067-0101-06 | TherafluSevere Cold Relief Combo Pack | 1 in 1 PACKET | POWDER, FOR SOLUTION | 1 | 25 mg | 1 |
| 0067-0101-06 | TherafluSevere Cold Relief Combo Pack | 6 in 1 CARTON | POWDER, FOR SOLUTION | 650 mg | 1 | |
| 0067-0122-01 | TherafluSevere Cold Relief Combo Pack | 1 in 1 PACKAGE, COMBINATION | KIT | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0067-0100 | THERAFLU SEVERE COLD RELIEF COMBO PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC] | 1 | Current NDC | 20240415_f147d82e-4429-4c7b-bd2b-e21a09f21c92.zip |
| 0067-0101 | THERAFLU SEVERE COLD RELIEF COMBO PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC] | 1 | Current NDC | 20240415_f147d82e-4429-4c7b-bd2b-e21a09f21c92.zip |
| 0067-0122 | THERAFLU SEVERE COLD RELIEF COMBO PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC] | 1 | Current NDC, 5 package rows | 20240415_f147d82e-4429-4c7b-bd2b-e21a09f21c92.zip |
Products#
Every source-derived product name is available through these pages.
- Theraflu Severe Cold Relief Combo Pack
- acetaminophen, dextromethorphan hbr, diphenhydramine hcl
- Theraflu Severe Cold Relief Daytime
- acetaminophen, dextromethorphan hbr
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- 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
- LECITHIN, SOYBEAN
- SUCROSE
- TRIBASIC CALCIUM PHOSPHATE
- Theraflu Severe Cold Relief Nighttime
- acetaminophen, diphenhydramine hcl
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0067-0122 | 0067-0122-01 |
| 0067-0100 | 0067-0100-06 |
| 0067-0101 | 0067-0101-06 |
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.