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Cold and Flu Relief Nighttime, Multi-Symptom

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 15mg, DOXYLAMINE SUCCINATE 6.25mg
Labeler: L.N.K. International, Inc.
NDC Code: 50844-660

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Quality Plus 44-660

Active ingredients
(in each liquid-filled capsule)

Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg 

Purpose

Pain reliever/fever reducer
Cough suppressant
Antihistamine 

Uses
  • temporarily relieves common cold and flu symptoms:
    • sore throat
    • minor aches and pains
    • headache
    • fever
    • runny nose and sneezing
    • 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 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
  • 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
  • to make a child sleepy
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have
  • liver disease
  • glaucoma
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema 
  • cough that occurs with too much phlegm (mucus)
  • difficulty in urination due to enlargement of the prostate gland

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
  • avoid alcoholic beverages
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery 

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
  • persistent cough lasts for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache

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 (1-800-222-1222) 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
  • do not take more than 8 capsules per 24 hours
  • adults and children 12 years and over: take 2 capsules with water every 6 hours
  • children under 12 years: ask a doctor

Other information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from heat, humidity and light
  • see end flap for expiration date and lot number

Inactive ingredients

D&C yellow #10, edible white ink, FD&C blue #1, gelatin, glycerin, lecithin, mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol 

Questions or comments?

1-800-426-9391 

Principal display panel

QUALITY
+ PLUS

*Compare to active ingredients in Vicks® NyQuil® Cold & Flu LiquiCaps®

MULTI-SYMPTOM

COLD &
FLU RELIEF

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
PAIN RELIEVER/FEVER REDUCER, COUGH SUPPRESSANT, ANTIHISTAMINE

• Headache       • Sneezing       • Fever
• Sore Throat    • Runny Nose   • Cough

16 Liquid Caps  

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA

*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® NyQuil® Cold & Flu LiquiCaps®.

50844   ORG021666021
Product of China
Packaged and Quality Assured in the USA

Quality Plus 44-660

COLD AND FLU RELIEF  NIGHTTIME, MULTI-SYMPTOM
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-660
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
MINERAL OIL 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize21mm
FlavorImprint Code660
Contains    
Packaging
#Item CodePackage Description
1NDC:50844-660-212 BLISTER PACK in 1 CARTON
18 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/01/2015
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIOperations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd421293287API MANUFACTURE(50844-660)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(50844-660)

Revised: 10/2017
 
L.N.K. International, Inc.

← See all Cold and Flu Relief Nighttime, Multi-Symptom brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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