COLD AND FLU DAYTIME/NIGHTIME- acetaminophen, dextromethorphan hbr, phenylephrine hcl, doxylamine succinate kit

Cold and Flu by

Drug Labeling and Warnings

Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Harmon Store Inc., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Daytime Cold & Flu

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 

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

Ask a doctor or pharmacist before use if the user has

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 (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
  
• 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
  
• 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, 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

Nighttime Cold & Flu

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
  
• 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

• 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)
• liver disease
  
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
• 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
  
• 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
  
• 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 (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
  
• 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

CORE VALUES™

Compare to the active ingredients in Vicks® DayQuil® Cold & Flu Multi-Symptom Relief & Vicks® NyQuil® Cold & Flu Nighttime Relief†

Daytime
Cold & Flu

Acetaminophen
Pain Reliever/Fever Reducer

Dextromethorphn HBr
Cough Suppressant

Phenylephrine
Nasal Decongestant

Non-Drowsy
Alcohol-Free

menthol flavor

 

Nighttime 
Cold & Flu

Acetaminophen
Pain Reliever/Fever Reducer

Dextromethorphan HBr
Cough Suppressant

Doxylamine succinate
Antihistamine

Alcohol-Free

eucalyptus Mint flavor

TWO - 12 FL OZ (355 mL) BOTTLES / TOTAL 24 FL OZ (710 mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED
NECK WRAP IS BROKEN OR MISSING

50844 REV0318A01201402

Distributed by: Liberty Procurement Co. Inc.
650 Liberty Ave., Union, NJ 07083 U.S.A.
Satisfaction Guaranteed Or Your Money Back
Visit us at www.facevalues.com

†These products are not manufactured or distributed by Procter & Gamble, owner of the registered trademark
VICKS® DayQuil® Cold & Flu Multi-Symptom Relief & VICKS® NyQuil® Cold & Flu Nighttime Relief.

44-012014

INGREDIENTS AND APPEARANCE

COLD AND FLU  DAYTIME/NIGHTIME
acetaminophen, dextromethorphan hbr, phenylephrine hcl, doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63940-124

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63940-124-02	1 in 1 PACKAGE; Type 0: Not a Combination Product	12/01/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	355 mL
Part 2	1 BOTTLE, PLASTIC	355 mL

Part 1 of 2

COLD AND FLU  DAYTIME
acetaminophen, dextromethorphan hbr, phenylephrine hcl liquid

Product Information
Item Code (Source)	NDC: 63940-912
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor	ORANGE, MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63940-912-02	355 mL in 1 BOTTLE, PLASTIC; 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	12/01/2018

Part 2 of 2

COLD AND FLU  NIGHTTIME
acetaminophen, dextromethorphan hbr, doxylamine succinate liquid

Product Information
Item Code (Source)	NDC: 63940-914
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor	MINT (Eucalyptus)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63940-914-02	355 mL in 1 BOTTLE, PLASTIC; 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	12/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/01/2018

Labeler - Harmon Store Inc. (804085293)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	MANUFACTURE(63940-124) , PACK(63940-124)