COLD AND FLU RELIEF MULTI-SYMPTOM, DAY, NIGHT- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl 
L.N.K. International, Inc.

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 44-659660-08-Delisted

Active ingredients
(in each liquid-filled capsule)

(Daytime Cold & Flu)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Active ingredients
(in each liquid-filled capsule)
(Nighttime Cold & Flu)

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:
  • fever
  • headache
  • sore throat
  • minor aches and pains
  • cough due to minor throat and bronchial irritation
  • nasal congestion (Daytime only)
  • runny nose and sneezing (Nighttime only)

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
  • more than 4,000 mg in 24 hours, which is the maximum daily amount 

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
  • to make a child sleepy (Nighttime only)

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • liver disease
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease (Daytime only)
  • diabetes (Daytime only)
  • thyroid disease (Daytime only)
  • high blood pressure (Daytime only)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema (Daytime only)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (Nighttime only)
  • glaucoma (Nighttime only)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nighttime only)

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children (Nighttime only)
  • avoid alcoholic beverages (Nighttime only)
  • marked drowsiness may occur (Nighttime only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
  • use caution when driving a motor vehicle or operating machinery (Nighttime only)

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur (Daytime only)
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days (Daytime only)
  • pain or cough gets worse or lasts more than 7 days (Nighttime only)
  • 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.

If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing.

Directions (Daytime only)

  • 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 4 hours
  • children under 12 years : ask a doctor

Directions (Nighttime only)

  • 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 (Daytime only)

edible white ink, FD&C red# 40 , FD&C yellow #6, gelatin, glycerin, lecithin, mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol

Inactive ingredients (Nighttime only)

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

NDC 50844-670-08

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

DAY/NIGHT
COMBO

MULTI-SYMPTOM
COLD & FLU RELIEF


Acetaminophen,
Dextromethorphan HBr,
Phenylephrine HCl

PAIN RELIEVER/FEVER REDUCER,
COUGH SUPPRESSANT,
NASAL DECONGESTANT

NON-DROWSY

16 Liquid Caps

Acetaminophen,
Dextromethorphan HBr,
Doxylamine Succinate

PAIN RELIEVER/FEVER REDUCER,
COUGH SUPPRESSANT,
ANTIHISTAMINE

8 Liquid Caps

24 Total Liquid Caps

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® DayQuil® & NyQuil® Cold & Flu LiquiCaps®.
50844  ORG021665966008
Product of China
Packaged and Quality Assured in the USA
Quality Plus 44-659660

Quality Plus 44-659660


COLD AND FLU RELIEF  MULTI-SYMPTOM, DAY, NIGHT
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-670
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50844-670-081 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product03/01/201503/29/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BLISTER PACK 16 
Part 21 BLISTER PACK
Part 1 of 2
COLD AND FLU RELIEF  MULTI-SYMPTOM, DAY
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GELATIN (UNII: 2G86QN327L)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize21mm
FlavorImprint Code 659
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2015
Part 2 of 2
COLD AND FLU RELIEF  MULTI-SYMPTOM, NIGHT
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
GELATIN (UNII: 2G86QN327L)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize21mm
FlavorImprint Code 660
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/201503/29/2019
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088pack(50844-670)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837pack(50844-670)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(50844-670)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(50844-670)

Revised: 5/2021
 
L.N.K. International, Inc.