Indications and uses
temporarily relieves common cold and flu symptoms: sore throat nasal congestion fever headache minor aches and pains cough due to minor throat and bronchial irritation
Cold and Flu Relief
- Manufacturer
- L.N.K. International, Inc. | LNK International, Inc.
- Effective date
- 2024-05-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:02:49
Label at a glance#
ProductCold and Flu Relief
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
do not take more than directed mL = milliliter; FL OZ = fluid ounce use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. do not take more than 5 doses per 24 hours adults and children 12 years and over 30 mL every 4 hours children 6 to under 12 years 15 mL every 4 hours children under 6 years do not use
Storage and handling
each 15 mL contains: sodium 13 mg use by expiration date on package store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Contacts and useful links#
Websitewww.stopmedicineabuse.org
www.StopMedicineAbuse.org
www.StopMedicineAbuse.orgLabel contents#
Full prescribing information#
Active ingredients (in each 15 mL)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Uses
- temporarily relieves common cold and flu symptoms:
- sore throat
- nasal congestion
- fever
- headache
- minor aches and pains
- cough due to minor throat and bronchial irritation
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
- child takes more than 5 doses in 24 hours
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
- 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 an MAOI, ask a doctor or pharmacist before taking this product.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if the user has
- thyroid disease
- difficulty in urination due to enlargement of the prostate gland
- heart disease
- liver disease
- diabetes
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- high blood pressure
Ask a doctor or pharmacist before use if the user is
taking the blood thinning drug warfarin.
When using this product
do not exceed recommended dosage.
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
- 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 accidental 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 take more than directed
- mL = milliliter; FL OZ = fluid ounce
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- do not take more than 5 doses per 24 hours
| adults and children 12 years and over | 30 mL every 4 hours |
| children 6 to under 12 years | 15 mL every 4 hours |
| children under 6 years | do not use |
Other information
- each 15 mL contains: sodium 13 mg
- use by expiration date on package
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive ingredients
anhydrous citric acid, FD&C yellow #6, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sodium saccharin, sorbitol, sucralose
Questions or comments?
1-800-426-9391
Principal display panel
QUALITY
+PLUS
NDC 50844-120-45
Compare to active ingredients
in Vicks® DayQuil® Cold & Flu
Multi-Symptom Relief*
Multi-Symptom
COLD & FLU RELIEF
Acetaminophen,
Dextromethorphan HBr,
Phenylephrine HCl
PAIN RELIEVER/FEVER REDUCER
COUGH SUPPRESSANT
NASAL DECONGESTANT
DAYTIME
Non-Drowsy
Alcohol Free
Menthol
Flavor
6 FL OZ (177 mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED
NECK WRAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Procter & Gamble,
owner of the registered trademark Vicks® DayQuil® Cold & Flu
Multi-Symptom Relief.
50844 REV0318A01245
Distributed by LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA
PARENTS:
Learn about teen medicine abuse
www.stopmedicineabuse.org
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Cold and Flu Relief
- Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- ANHYDROUS CITRIC ACID
- FD&C YELLOW NO. 6
- GLYCERIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- TRISODIUM CITRATE DIHYDRATE
- SODIUM METABISULFITE
- SACCHARIN SODIUM
- SORBITOL
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50844-120 | 50844-120-45 |
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 |
|---|---|---|---|---|---|---|
| 770aadb8-4da5-4120-90ab-2dd76290edad | 0c2ffb7a-b896-4ea1-9695-bc91eeb2a700 | 2025-05-10 | Warnings | 0c2ffb7a-b896-4ea1-9695-bc91eeb2a700 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.