• temporarily relieves these symptoms due to a cold: • minor aches and pains • minor sore throat pain • headache • nasal and sinus congestion • 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
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...
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
Pain reliever/Fever reducer
Antihistamine/Cough suppressant
• temporarily relieves these symptoms due to a cold: • minor aches and pains • minor sore throat pain • headache • nasal and sinus congestion • 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
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.
• 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.
you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • 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
before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin
• 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
• 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, cough or nasal congestion gets worse or lasts more than 7 days These could be signs of a serious condition.
ask a health professional before use.
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.
do not use more than directedtake 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.
• 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.
acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, f lavors, maltodextrin, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate
1-855-328-5259
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2670677 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG Powder for Oral Solution | PSN | 1 |
| 2670677 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral Solution | SCD | 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 |
| 2670677 | APAP 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral Solution | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50269-101-06 | THERAFLU SEVERE COLD RELIEF NIGHTTIME | 1 in 1 PACKET | POWDER, FOR SOLUTION | 1 | 1 | |
| 50269-101-06 | THERAFLU SEVERE COLD RELIEF NIGHTTIME | 20 in 1 BOX | POWDER, FOR SOLUTION | 20 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50269-101 | THERAFLU SEVERE COLD RELIEF NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) POWDER, FOR SOLUTION [JC WORLD BELL WHOLESALE CO., INC.] | 1 | 2 package rows | 20240523_6ee1cc52-2d7e-4b53-a0e6-563e623bcb51.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50269-101 | 50269-101-06 |
| 0067-0101 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| 1907b4ac-fdc0-b407-e063-6294a90a344d | 6ee1cc52-2d7e-4b53-a0e6-563e623bcb51 | 2024-05-22 | Warnings | 1907b4ac-fdc0-b407-e063-6294a90a344d 6ee1cc52-2d7e-4b53-a0e6-563e623bcb51 | ||
| Theraflu Severe Cold Relief Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | 14e38ef0-a5e7-4df7-824f-f27bef664d25 | 2024-03-08 | Warnings | 0067-0101 |
Adverse event summaries are temporarily unavailable. Other product information remains available.