Indications and uses
temporarily relieves common cold and flu symptoms: runny nose and sneezing fever sore throat 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
- 2024-07-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 10
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:58:47
Label at a glance#
ProductCold and Flu Relief Multi-Symptom
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
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 4 doses per 24 hours adults and children 12 years and over: 30 mL every 6 hours children under 12 years: do not use
Storage and handling
each 30 mL contains: sodium 18 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each 30 mL)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Uses
- temporarily relieves common cold and flu symptoms:
- runny nose and sneezing
- fever
- sore throat
- 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 you take
- more than 4,000 mg of acetaminophen in 24 hours
- 3 or more alcoholic drinks every day while using this product
- with other drugs containing acetaminophen
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 you have
- difficulty in urination due to enlargement of the prostate gland
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- liver disease
- glaucoma
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- do not exceed recommended dosage
- excitability may occur, especially in children
- alcohol, sedatives, and tranquilizers may increase drowsiness
- marked drowsiness may occur
- use caution when driving a motor vehicle or operating machinery
- avoid alcoholic beverages
Stop use and ask a doctor if
- pain or cough gets worse or lasts more than 7 days
- 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. 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 4 doses per 24 hours
- adults and children 12 years and over: 30 mL every 6 hours
- children under 12 years: do not use
Other information
- each 30 mL contains: sodium 18 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Inactive ingredients
anhydrous citric acid, D&C yellow #10, FD&C green #3, FD&C yellow #6, flavors, glycerin, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sodium saccharin, sucralose
Questions or comments?
1-800-426-9391
Principal display panel
QUALITY
+PLUS
NDC 50844-014-45
Compare to active ingredients
in Vicks® NyQuil® Cold & Flu
Nighttime Relief*
Multi-Symptom
COLD & FLU RELIEF
Acetaminophen,
Dextromethorphan HBr,
Doxylamine succinate
PAIN RELIEVER/FEVER REDUCER
COUGH SUPPRESSANT
ANTIHISTAMINE
NIGHTTIME
Alcohol Free
Eucalyptus Mint
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® NyQuil® Cold & Flu Nighttime
Relief. 50844 REV0318A01445
Distributed by LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA
Products#
Every source-derived product name is available through these pages.
- Cold and Flu Relief Multi-Symptom
- Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- ANHYDROUS CITRIC ACID
- D&C YELLOW NO. 10
- FD&C GREEN NO. 3
- FD&C YELLOW NO. 6
- GLYCERIN
- HIGH FRUCTOSE CORN SYRUP
- POLYETHYLENE GLYCOL, UNSPECIFIED
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SODIUM CHLORIDE
- TRISODIUM CITRATE DIHYDRATE
- SACCHARIN SODIUM
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50844-014 | 50844-014-45 |
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 |
|---|---|---|---|---|---|---|
| 4a91d7c1-bed7-4f2b-a900-d9c0a76d2c9b | 135b2e99-92d1-4312-8ff9-ca44368f6874 | 2024-07-17 | Warnings | 4a91d7c1-bed7-4f2b-a900-d9c0a76d2c9b 135b2e99-92d1-4312-8ff9-ca44368f6874 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.