Temporarily relieves these symptoms due to a cold •minor aches and pains •minor sore throat pain •sneezing •headache •nasal and sinus congestion •itchy, watery eyes due to hay fever •cough due to minor throat and bronchial irritation •temporarily reduces fever.
•do not use more than directed (see Overdose Warning) •take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor. • children under 4 years of age: do not use •children 4 to 12 years of age: do not use unless directed by a doctor •Adults and children over 12 years of age: One packet •dissolve contents of one packet into 8 oz hot water, sip while hot. Consume...
•This product does not contain Aspartame •store at a controlled room temperature 20-25C (68-77F). Protect from excessive heat & moisture.
Acetaminophen 650 mg
Diphenhydramine HCI 25 mg
Phenylephrine hydrochloride 10 mg
Pain reliever / Fever reducer
Antihistamine/Cough suppressant
Nasal decongestant
Temporarily relieves these symptoms due to a cold
•minor aches and pains
•minor sore throat pain
•sneezing
•headache
•nasal and sinus congestion
•itchy, watery eyes due to hay fever
•cough due to minor throat and bronchial irritation
•temporarily reduces fever.
Liver Warning-This product contains acetaminophen; Sever liver damage may occur if you take
•more than 4000mg 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 sever skin reactions.
Symptoms may include:
•skin reddening
•blisters
•rash
•If 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 a fever, headache, rash, nausea or vomiting, consult a doctor promptly
lf you have ever had an allergic reaction to this product or any of its ingredients
•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 MAOI, ask a doctor or pharmacist before taking this product.
•liver disease
•heart disease
•high blood pressure
•thyroid disease
•diabetes
•glaucoma
•trouble urinating due to enlarged prostate gland
•cough that occurs with too much phlegm (mucus)
•a breathing problem such as emphysema or chronic bronchitis
•cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
•taking sedatives or tranquilizers
•taking the blood thinning drug warfarin.
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.
•new symptoms occur
•nervousness, dizziness, or sleeplessness occurs
•fever gets worse or lasts more than 3 days
•redness or swelling is present
•new symptoms occur
•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.
ask a health care professional before use.
Overdose warning. In case of overdose, get medical help or contact a Poison Control Center right away (1 800 222-1222).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 directed (see Overdose Warning)
•take every 4 hours, while symptoms persist. Do not take more than 5
packets in 24 hours unless directed by a doctor.
•
children under 4 years of age: do not use
•children 4 to 12 years of age: do not use unless directed by a doctor
•Adults and children over 12 years of age: One packet
•dissolve contents of one packet into 8 oz hot water, sip while hot.
Consume entire drink within 10-15 minutes using a microwave, add contents of one packet to 8 oz cool water, stir briskly before and after heating. Do not overheat.
•This product does not contain Aspartame
•store at a controlled room temperature 20-25C (68-77F). Protect from excessive heat & moisture.
Sucrose, Sucralose,Maltodextrin, FD&C Yellow #10, Citric Acid, Colloidal Silicon Dioxide, Flavors, Tribasic Calcium Phosphate.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63561-0128-6 | 2021-05-14 | C162847 | 48780-1 | 9d75b9d0-1087-f424-e053-dadaa90a57ce | FLU-MED NIGHTTIME SEVERE COLD & COUGH Honey Lemon Infused with Camomile & White Tea Flavors |
| 63561-0128-6 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-1087-f424-e053-dadaa90a57ce | FLU-MED NIGHTTIME SEVERE COLD & COUGH Honey Lemon Infused with Camomile & White Tea Flavors |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 63561-0128 | 63561-0128-6 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SUCROSE | C151H8M554 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| CITRIC ACID ACETATE | DSO12WL7AU | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| TRIBASIC CALCIUM PHOSPHATE | 91D9GV0Z28 | 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 |
|---|---|---|---|---|---|---|
| c24d0c86-3448-3577-e053-2a95a90aa1a7 | 0911ef0b-2ec4-4a78-b477-52700e453a66 | 2021-05-14 | Warnings | 0911ef0b-2ec4-4a78-b477-52700e453a66 |
Adverse event summaries are temporarily unavailable. Other product information remains available.