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

Multi-Symptom Daytime and Nighttime Cold and Flu Relief Plus by

Drug Labeling and Warnings

Multi-Symptom Daytime and Nighttime Cold and Flu Relief Plus by is a Otc medication manufactured, distributed, or labeled by Walgreens Company, Apotex Inc., Accucaps Industries Limited, Accucaps Industries Limited Strathroy, Legacy Pharmaceutical Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients for DAYTIME ONLY (in each LiquidCap)

Acetaminophen

Dextromethorphan hydrobromide

Phenylephrine hydrochloride

Active ingredients for NIGHTTIME (in each LiquidCap)

Acetaminophen

Dextromethorphan hydrobromide

Doxylamine succinate

Phenylephrine hydrochloride

Purpose (DAYTIME ONLY)

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Purpose (NIGHTTIME ONLY)

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses (DAYTIME ONLY)

temporarily relieves these symptoms due to a cold or flu:

• minor aches and pains
• headache
• cough
• nasal and sinus congestion
• temporarily reduces fever

Uses (NIGHTTIME ONLY)

temporarily relieves these symptoms due to a cold or flu:

• minor aches and pains
• headache
• nasal and sinus congestion
• cough
• sore throat
• runny nose
• temporarily reduces fever

Warnings (DAYTIME ONLY)

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

• more than 10 capsules in 24 hours, 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.

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 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.
• in children under 12 years of age

Ask a doctor before use if you have

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

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 

Stop use and ask doctor if

• 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
• nervousness, dizziness, or sleeplessness occurs

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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.

Warnings (NIGHTTIME ONLY)

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

• more than 10 capsules in 24 hours, 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.

Do not use to sedate children.

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 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.
• in children under 12 years of age

Ask a doctor before use if you have

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

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

Stop use and ask doctor if

• 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
• nervousness, dizziness, or sleeplessness occurs

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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 (DAYTIME ONLY)

• do not take more than the recommended dose
• adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor.
• children under 12 years: do not use

Directions (NIGHTTIME)

• do not take more than the recommended dose
• adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor.
• children under 12 years: do not use

Other Information

• store at controlled room temperature 15°C to 30°C (59°F to 86°F)

Inactive ingredients (DAYTIME ONLY)

FD&C red #40, FD&C yellow #6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sortitian, sorbitol

Inactive ingredients (NIGHTTIME)

D&C yellow #10, FD&C blue #1, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sortitian, sorbitol

Questions or comments?

1-800-706-5575

Principal Display Panel

Combo Pack

MULTI-SYMPTOM NON-DROWSY DAYTIME

Cold & Flu Relief Plus

Acetaminophen

Aches/Fever/Sore Throat

Dextromethorphan HBr/Cough

Phenylephrine HCl/Nasal Congestion

12 LIQUID GELS

MULTI-SYMPTOM NIGHTTIME

Cold & Flu Relief Plus

Aches/Fever/Sore Throat

Dextromethorphan HBr/Cough

Doxylamine Succinate/Sneezing/Runny Nose

8 LIQUID CAPS

Compare to Alka Seltzer PLUS® active ingredients‡‡

20 TOTAL LIQUID GELS

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-1031

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-1031-02	1 in 1 CARTON; Type 1: Convenience Kit of Co-Package

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BLISTER PACK	12
Part 2	1 BLISTER PACK	8

Part 1 of 2

MULTI-SYMPTOM DAY TIME COLD AND FLU RELIEF PLUS 
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)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
MANNITOL (UNII: 3OWL53L36A)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	ORANGE	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	95A
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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	03/01/2013

Part 2 of 2

MULTI-SYMPTOM NIGHT TIME COLD AND FLU RELIEF PLUS 
acetaminophen, dextromethorphan hydrobromide, 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	10 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	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 GLYCOLS (UNII: 3WJQ0SDW1A)
POVIDONES (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	GREEN	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	35A
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	03/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/01/2014

Labeler - Walgreens Company (008965063)

Registrant - Apotex Inc. (209429182)

Establishment
Name	Address	ID/FEI	Business Operations
Accucaps Industries Limited		248441727	analysis(0363-1031) , manufacture(0363-1031)

Establishment
Name	Address	ID/FEI	Business Operations
Accucaps Industries Limited Strathroy		243944050	analysis(0363-1031) , manufacture(0363-1031)

Establishment
Name	Address	ID/FEI	Business Operations
Legacy Pharmaceutical Packaging		969852743	pack(0363-1031)