COLD AND FLU RELIEF MULTI-SYMPTOM, DAY, NIGHT- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

Cold and Flu Relief by

Drug Labeling and Warnings

Cold and Flu Relief by is a Otc medication manufactured, distributed, or labeled by L.N.K. International, Inc., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

COLD AND FLU RELIEF  MULTI-SYMPTOM, DAY, NIGHT
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50844-670

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50844-670-08	1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product	03/01/2015

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	2 BLISTER PACK	16
Part 2	1 BLISTER PACK	8

Part 1 of 2

COLD AND FLU RELIEF  MULTI-SYMPTOM, DAY
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	ORANGE	Score	no score
Shape	OVAL	Size	21mm
Flavor		Imprint Code	659
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/01/2015

Part 2 of 2

COLD AND FLU RELIEF  MULTI-SYMPTOM, NIGHT
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	GREEN	Score	no score
Shape	OVAL	Size	21mm
Flavor		Imprint Code	660
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/01/2015

Labeler - L.N.K. International, Inc. (038154464)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(50844-670)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(50844-670)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(50844-670)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(50844-670)