Indications and uses
Temporarily relieves these symptoms due to a cold •minor aches and pains •minor sore throat pain •headache •nasal and sinus congestion •cough due to minor throat and bronchial irritation •temporarily reduces fever.
FLU-MED
- Manufacturer
- GRANULATION TECHNOLOGY, INC.
- Effective date
- 2018-02-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:02:51
Label at a glance#
ProductFLU-MED DAYTIME SEVERE COLD and COUGH non drowsy formula
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
•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...
Storage and handling
•This product does not contain Aspartame •store at a controlled room temperature 20-25C (68-77F). Protect from excessive heat & moisture.
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each packet)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Phenylephrine hydrochloride 10 mg
Purposes
Pain reliever / Fever reducer
Cough suppressant
Nasal decongestant
Uses
Temporarily relieves these symptoms due to a cold
•minor aches and pains
•minor sore throat pain
•headache
•nasal and sinus congestion
•cough due to minor throat and bronchial irritation
•temporarily reduces fever.
Warnings
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
Do not use
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.
Ask doctor before use if you have
•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
•a sodium restricted diet.
Ask a doctor or pharmacist before use if you are
•taking sedatives or tranquilizers
•taking the blood thinning drug warfarin.
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
•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.
If pregnant or breast-feeding,
ask a health care professional before use.
Keep out of reach of children.
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.
Directions
•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.
Other information
•This product does not contain Aspartame
•store at a controlled room temperature 20-25C (68-77F). Protect from excessive heat & moisture.
Inactive ingredients
Sucrose, Sucralose,Maltodextrin, FD&C Red #40, FD&C Blue #1, Citric Acid, Colloidal Silicon Dioxide, Flavors, Tribasic Calcium Phosphate.
Outer Package
Inner Package
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63561-0129-6 | 2021-05-14 | C162847 | 48780-1 | 9d75b9d0-94d5-f424-e053-dadaa90a57ce | FLU-MED DAYTIME SEVERE COLD & COUGH non drowsy formula Mixed Berry Green Tea with Menthol Flavor |
| 63561-0129-6 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-94d5-f424-e053-dadaa90a57ce | FLU-MED DAYTIME SEVERE COLD & COUGH non drowsy formula Mixed Berry Green Tea with Menthol Flavor |
Products#
Every source-derived product name is available through these pages.
- FLU-MED DAYTIME SEVERE COLD and COUGH non drowsy formula
- ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE
- SUCROSE
- SUCRALOSE
- MALTODEXTRIN
- FD&C RED NO. 40
- FD&C BLUE NO. 1
- CITRIC ACID ACETATE
- SILICON DIOXIDE
- TRIBASIC CALCIUM PHOSPHATE
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63561-0129 | 63561-0129-6 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SUCROSE | C151H8M554 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| CITRIC ACID ACETATE | DSO12WL7AU | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| TRIBASIC CALCIUM PHOSPHATE | 91D9GV0Z28 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
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 |
|---|---|---|---|---|---|---|
| c24cda14-9e0d-53f5-e053-2995a90a624e | 7f62773d-e6be-4ec6-8375-59944c28163d | 2021-05-14 | Warnings | 7f62773d-e6be-4ec6-8375-59944c28163d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.