SEVER DAYTIME COLD AND FLU AND SEVER NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride kit

sever daytime cold and flu and sever nighttime cold and flu by

Drug Labeling and Warnings

sever daytime cold and flu and sever nighttime cold and flu by is a Otc medication manufactured, distributed, or labeled by Kmart Corporation, Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each softgel)

DAYTIME SEVERE COLD AND FLU 

Acetaminophen 325 mg 

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg 

Phenylephrine HCl 5mg

Active ingredients (in each softgel)

NIGHTTIME SEVERE COLD AND FLU

Acetaminophen 325 mg 

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg 

Phenylephrine HCl 5mg

Purpose

DAYTIME SEVERE COLD AND FLU

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Purposes

NIGHTTIME SEVERE COLD AND FLU

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

• temporarily relieves common cold/flu symptoms:
• nasal congestion
• sinus congestion & pressure
• cough due to minor throat & bronchial irritation
• cough to help you sleep (Nighttime only)
• minor aches & pains
• headache
• fever
• sore throat
• runny nose & sneezing (Nighttime only)

• reduces swelling of nasal passages
• temporarily restores freer breathing through the nose
• promotes nasal and/or sinus drainage
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Liver warning

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

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

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.

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.

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.
• to make a child sleep (Nighttime only)

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, 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 use more than directed

Nighttime only:

• excitability may occur, especially in children
• marked drowsiness may occur
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• pain, nasal congestion, 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.

Overdose warning

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• take only as directed - see Overdose warning
• do not exceed 4 doses per 24 hrs

• adults & children 12 yrs and over:

  2 softgels with water every 4 hrs

• children 4 to under 12 yrs:

  ask a doctor

• children under 4 yrs:

  do not use

• when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Other information

• store at room temperature 15º-30ºC (59º-86ºF)and avoid excessive heat

Inactive ingredients

DAYTIME SEVERE COLD AND FLU

FD&C yellow #6, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol sorbitan solution, and white edible ink

Inactive ingredients

NIGHTTIME SEVERE COLD AND FLU

FD&C blue #1, D&C yellow #10, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol sorbitan solution, and white edible ink

Questions or comments?

Call toll free: 1-800-842-7886

Principal Display Panel - Carton Label

Severe daytime cold & flu and severe nighttime cold & flu 24ct

NDC: 49738-036-04

*Compare to the active ingredients in Vicks® DayQuil® Severe and NyQuil® Severe Cold and Flu

INGREDIENTS AND APPEARANCE

SEVER DAYTIME COLD AND FLU AND SEVER NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49738-036

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49738-036-04	1 in 1 CARTON; Type 0: Not a Combination Product	07/12/2017

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BLISTER PACK	12
Part 2	1 BLISTER PACK	12

Part 1 of 2

SEVERE DAYTIME COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride 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
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	orange (clear)	Score	no score
Shape	capsule (oblong)	Size	26mm
Flavor		Imprint Code	PC26
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 CARTON
1		12 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	07/12/2017

Part 2 of 2

SEVERE NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride 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
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	green	Score	no score
Shape	capsule (oblong)	Size	21mm
Flavor		Imprint Code	PC22
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 CARTON
1		12 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	07/12/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/12/2017

Labeler - Kmart Corporation (008965873)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd		421293287	manufacture(49738-036) , analysis(49738-036)