Active ingredients (in each packet) Purpose
Acetaminophen 650 mg .......................................Pain reliever/Fever reducer
Diphenhydramine hydrochloride 25 mg ........Antihistamine/Cough suppressant
Phenylephrine hydrochloride 10 mg .................................Nasal decongestant
Uses
- 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 and throat - itchy, watery eyes due to hay fever
- 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 6 packets in 24 hours, which is the maximum daily amount - 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 4 years of age
- If you are allergic to Acetaminophen
- with any other drug containing acetaminophen (prescription and non prescription). 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 a MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if 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, asthma, 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.
- a sodium restricted diet.
Ask a doctor or pharmacist before use if you are
When using this product
- do not exceed recommended dosage
- 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
- nervousness, dizziness, or sleeplessness occurs
- fever gets worse or lasts more than 3 days - redness or swelling is present
- new symptoms occur - symptoms do not get better or worsen
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health care 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; not to exceed 6 packets in 24 hours or as directed by a doctor.
| Age | Dose |
| children under 4 years of age | do not use |
| children 4 to under 12 years of age | do not use unless directed by a doctor |
| adults and children 12 years of age and over | one packet |
- 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 7 mg, sodium 46 mg
- phenylketonurics: each packet contains phenylalanine 13 mg
- store at controlled room temperature 20-25C (68-77F). Protect from heat and moisture.
Acesulfame potassium, anhydrous citric acid, aspartame, caramel, D and C Yello 10, maltodextrin, natural flavors, sodium citrate, starch and sugar.
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1659960 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution | PSN | 1 |
| 1659960 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution | SCD | 1 |
| 1659960 | acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral Solution | SY | 1 |
| 1659960 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution | SY | 1 |
| 1659960 | APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0840986024658 | GTIN-13: 0840986024658 EAN-13: 0840986024658 GTIN-12: 840986024658 UPC-A: 840986024658 GTIN storage (14 digits): 00840986024658 | carton.jpg |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68016-755-06 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-cee6-f424-e053-dadaa90a57ce | night time severe cold and cough honey lemon infused with chamomile and white tea flavors |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68016-755-06 | Premier Value night time severe cold and coughhoney lemon infused with chamomile and white tea flavors | 6 in 1 BOX | GRANULE, FOR SOLUTION | 6 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68016-755 | PREMIER VALUE NIGHT TIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [PREMIER VALUE] | 1 | Legacy NDC, 1 package rows | 20160324_2ecf321a-6073-30bd-e054-00144ff88e88.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68016-755 | 68016-755-06 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACESULFAME | MA3UYZ6K1H | IACT |
| ASPARTAME | Z0H242BBR1 | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SUCROSE | C151H8M554 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
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 |
|---|---|---|---|---|---|---|
| 2ecdec89-6ee6-29d9-e054-00144ff8d46c | 2ecf321a-6073-30bd-e054-00144ff88e88 | 2016-03-24 | Warnings | 2ecdec89-6ee6-29d9-e054-00144ff8d46c 2ecf321a-6073-30bd-e054-00144ff88e88 |
Adverse event summaries are temporarily unavailable. Other product information remains available.