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

Cold and Flu Relief by

Drug Labeling and Warnings

Cold and Flu Relief by is a Otc medication manufactured, distributed, or labeled by WinCo Foods, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients in Daytime (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Active ingredients in Nighttime (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose for Daytime

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Purpose for Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

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

Warnings

Liver warning: These products contain 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.

Ask a doctor before use if you have

• liver disease (Daytime-Nighttime)
• heart disease (Daytime)
• diabetes (Daytime)
• thyroid disease (Daytime) 
• high blood pressure (Daytime)
• glaucoma (nighttime)
• cough that occurs with too much phlegm (mucus)
• trouble urinating due to an enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, emphysema (Daytime)
• a breathing problem or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema (Nighttime)

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,

Daytime: do not use more than directed.

Nighttime:

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

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur (Daytime only)
• pain, cough, and nasal congestion gets worse or lasts more than 7 days (Daytime)
• pain or cough gets worse or lasts more than 3 days (Nighttime)  
• 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 the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick 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 (see Overdose warning )
• do not take more than 4 doses in 24 hours
• swallow whole; do not crush, chew, or dissolve

Daytime: adults and children 12 years and over: take 2 softgels with water every 4 hours

Nighttime: adults and children 12 years and over: take 2 softgels with water every 6 hours

• children under 12 years: do not use

Other information

• store at room temperature 15°-30°C (59°-86°F)
• avoid excessive heat

Inactive ingredeints for Daytime

butylated hydroxyanisole, butylated hydroxytoluene, carminic acid*, D&C yellow #10*, edible white ink, FD&C red #40*, FD&C yellow #6*, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sodium metabisulfite*, sorbitan, sorbitol

*contains one or more of these ingredients

Inactive ingredients in Nighttime

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

*may contain this ingredient

Questions or comments?

Or to report an adverse event call 800-824-1706 Monday-Friday 9am-4pm MST

Principal Display Panel

**Compare to the Active Ingredients in VICKS® DAYQUIL® & NyQUIL® LiquiCaps®

Multi-Symptom Cold & Flu Relief

NON-DROWSY

DAYTIME

ACETAMINOPHEN / PAIN RELIEVER - FEVER REDUCER

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

PHENYLEPHRINE HCI / NASAL DECONGESTANT 

Relieves: Aches, Fever, Sore Throat, Cough & Nasal Congestion

Nighttime

ACETAMINOPHEN / PAIN RELIEVER - FEVER REDUCER

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

DOXYLAMINE SUCCINATE / ANTIHISTAMINE

Relieves: Aches, Fever, Sore Throat, Cough, Sneezing & Runny Nose.

Softgels

**Liquid Filled Capsules

When using Daytime and Nighttime products, carefully read the labeling to ensure correct dosing.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

†This product is not manufactured or distributed by THE PROCTER & GAMBLE COMPANY, VICKS®, DAYQUIL®, NYQUIL® AND LiquiCap® are registered trademarks of THE PROCTER & GAMBLE COMPANY.

DISTRIBUTED BY:

WINCO FOODS, LLC

BOISE, ID 83704

www.wincofoods.com

Product Label

WinCo Foods DayTime NightTime Multi-Symptom Cold & Flu Relief

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67091-309

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67091-309-48	1 in 1 CARTON; Type 0: Not a Combination Product	09/30/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	16 BLISTER PACK	16
Part 2	32 BLISTER PACK	32

Part 1 of 2

COLD AND FLU RELIEF  MULTI SYMPTOM NIGHTTIME
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule

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)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	GREEN	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	P30;94A;215;P120
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		16 in 1 CARTON
1		1 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

Part 2 of 2

COLD AND FLU RELIEF  MULTI SYMPTOM NON DROWSY DAYTIME
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule

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
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
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)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
CARMINIC ACID (UNII: CID8Z8N95N)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)

Product Characteristics
Color	ORANGE	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	P19;95A;512;P119
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		32 in 1 CARTON
1		1 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	09/30/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	09/30/2016

Labeler - WinCo Foods, LLC (056098817)