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 Severe Cold Relief Daytime Berry Burst
- Manufacturer
- Haleon US Holdings LLC
- Effective date
- 2024-03-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:09:38
Label at a glance#
ProductTheraflu Severe Cold Relief Daytime Berry Burst
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections
Dosage and administration
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...
Storage and handling
each packet contains: potassium 5 mg, sodium 20 mg phenylketonurics: contains phenylalanine 14 mg per packet store at controlled room temperature 20 o -25 o C (68 o - 77 o F). Protect product from heat and moisture.
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)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Purposes
Pain reliever/Fever reducer
Cough suppressant
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
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 a 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 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.
Directions
- 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
- each packet contains:potassium 5 mg, sodium 20 mg
- phenylketonurics:contains phenylalanine 14 mg per packet
- store at controlled room temperature 20 o-25 oC (68 o- 77 oF). Protect product from heat and moisture.
Inactive ingredients
acesulfame potassium, anhydrous citric acid, aspartame, 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?
1-855-328-5259
Additional information
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.
KEEP CARTON FOR REFERENCE. DO NOT DISCARD.
PARENTS:
Learn about teen medicine abuse
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
62000000207731
Principal Display
NEW FORMULA
HALEON
THERAFLU
SEVERE COLD RELIEF
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
DAYTIME FORMULA
Hot liquid therapy that relieves:
- / Cough
/ Sore throat pain
/ Head and body ache
/ Fever
Berry Burst Flavor
6 PACKETS
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2670678 | acetaminophen 650 MG / dextromethorphan HBr 20 MG Powder for Oral Solution | PSN | 2 |
| 2670678 | acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution | SCD | 2 |
| 2670678 | acetaminophen 650 MG / dextromethorphan HBr 20 MG Granules for Oral Solution | SY | 2 |
| 2670678 | acetaminophen 650 MG / dextromethorphan HBr 20 MG Packet for Oral Solution | SY | 2 |
| 2670678 | APAP 650 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution | SY | 2 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0067-0106-06 | Theraflu Severe Cold Relief Daytime Berry Burst | 6 in 1 CARTON | POWDER, FOR SOLUTION | 6 | 2 | |
| 0067-0106-06 | Theraflu Severe Cold Relief Daytime Berry Burst | 1 in 1 PACKET | POWDER, FOR SOLUTION | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0067-0106 | THERAFLU SEVERE COLD RELIEF DAYTIME BERRY BURST (ACETAMINOPHEN, DEXTROMETHORPHAN HBR) POWDER, FOR SOLUTION [HALEON US HOLDINGS LLC] | 2 | Current NDC, 2 package rows | 20240310_adf33520-4689-4de2-b9d8-c201518e9d26.zip |
Products#
Every source-derived product name is available through these pages.
- Theraflu Severe Cold Relief Daytime Berry Burst
- ACETAMINOPHEN, DEXTROMETHORPHAN HBr
- ACESULFAME POTASSIUM
- ANHYDROUS CITRIC ACID
- ASPARTAME
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- MALTODEXTRIN
- SILICON DIOXIDE
- SODIUM CITRATE, UNSPECIFIED FORM
- LECITHIN, SOYBEAN
- SUCROSE
- TRIBASIC CALCIUM PHOSPHATE
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0067-0106 | 0067-0106-06 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Theraflu Severe Cold Relief Daytime Berry Burst | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | adf33520-4689-4de2-b9d8-c201518e9d26 | 2024-03-08 | Warnings | 0067-0106-06 0067-0106 00067010606 132dee3d-4a55-2c83-e063-6294a90a6729 adf33520-4689-4de2-b9d8-c201518e9d26 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.