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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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MULTI-SYMPTOM DAYTIME AND NIGHTTIME COLD & FLU RELIEF PLUS

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.

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

cold-and-flu-relief-plus-combo-ctn

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-1031-02	1 in 1 CARTON; Type 1: Convenience Kit of Co-Package	09/01/2014	08/14/2020

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
MANNITOL (UNII: 3OWL53L36A)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	03/01/2013	08/14/2020

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (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

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	03/01/2013	08/14/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	09/01/2014	08/14/2020

Labeler - Walgreens Company (008965063)

Registrant - Apotex Inc. (209429182)

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

Name	Address	ID/FEI	Business Operations
Establishment
Catalent Ontario Limited		243944050	analysis(0363-1031) , manufacture(0363-1031)

Name	Address	ID/FEI	Business Operations
Establishment
Legacy Pharmaceutical Packaging, LLC		143213275	pack(0363-1031)

Revised: 8/2020

Document Id: 0027cc72-127f-453c-8221-375bbdb91d42

Set id: 7b23d8dc-3ca0-90a9-964e-9ca2dfdf64b0

Version: 2

Effective Time: 20200814

Walgreens Company