DAYTIME AND NIGHTTIME COLD AND FLU RELIEF PLUS- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit

Daytime and Nighttime Cold and Flu Relief Plus by

Drug Labeling and Warnings

Daytime and Nighttime Cold and Flu Relief Plus by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, LLC, Accucaps Industries Limited, Accucaps Industries Limited Strathroy, Legacy Pharmaceutical Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each capsule) for DAY TIME

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg

Active ingredients (in each capsule) for NIGHT TIME

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine hydrochloride 5 mg

Purposes (DAY TIME)

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Purposes (NIGHT TIME)

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses (DAY TIME)

• temporarily relieves these symptoms due to a cold or flu:

• minor aches and pains

• headache

• cough

• sore throat

• nasal and sinus congestion

• temporarily reduces fever

Uses (NIGHT TIME)

• temporarily relieves these symptoms due to a cold or flu:

• minor aches and pains

• headache

• nasal and sinus congestion

• cough

• sore throat

• runny nose

• sneezing

• temporarily reduces fever

Warnings (DAY TIME)

Liver warnings: This product contains acetaminophen.

Sever 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

Allergy Alert: acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

• skin reddening
• blisters
• rash
• hives
• facial swelling
• asthma (wheezing)
• shock

If a skin or general allergic 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

• 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.

When using this product do not exceed recommended dosage.

Stop use and ask a doctor if

• pain, cough, or nasal congestion gets worse or lasts more than 7 dayspain, cough, or nasal congestion 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.

• 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 (NIGHT TIME)

Liver warnings: This product contains acetaminophen.

Sever 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

Allergy Alert: acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

• skin reddening
• blisters
• rash
• hives
• facial swelling
• asthma (wheezing)
• shock

If a skin or general allergic 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 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 have ever had an allergic reaction to this product or any of its ingredients

• 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

• may cause marked drowsiness

• 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 a doctor if

• pain, cough, or nasal congestion gets worse or lasts more than 7 dayspain, cough, or nasal congestion 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.

• 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 (DAY TIME and NIGHT TIME)

• 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 (DAY TIME and NIGHT TIME)

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

• do not use if blister seal is ripped or broken

Inactive ingredients (DAY TIME

FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerine, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution and white ink

Inactive ingredients (NIGHT TIME)

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerine, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution and white ink

Questions or comments? (DAY TIME and NIGHT TIME)

1-800-706-5575

*This product is not manufactured or distributed by Bayer HealthCare LLc., distributor of Alka-Seltzer PLUS®.

Principal Display Panel

MULTI-SYMPTOM NON-DROWSY - DAY TIME

Cold & Flu Relief Plus

NDC number 68016-721-20

12 Liquid Gels 

MULTI-SYMPTOM NON-DROWSY - NIGHT TIME

Cold & Flu Relief Plus

NDC number 68016-721-20

8 Liquid Gels

INGREDIENTS AND APPEARANCE

DAYTIME AND NIGHTTIME COLD AND FLU RELIEF PLUS 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-721

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-721-20	1 in 1 CARTON; Type 1: Convenience Kit of Co-Package

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

Part 1 of 2

DAYTIME COLD AND FLU RELIEF PLUS 
acetaminophen, dextromethorphan hydrobromide, 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
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)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POVIDONES (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	ORANGE	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	95A
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	09/17/2015

Part 2 of 2

NIGHTTIME COLD AND FLU RELIEF PLUS 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, 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	CAPSULE	Size	16mm
Flavor		Imprint Code	94A
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	09/17/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/17/2015

Labeler - Chain Drug Consortium, LLC (101668460)

Establishment
Name	Address	ID/FEI	Business Operations
Accucaps Industries Limited		248441727	analysis(68016-721) , manufacture(68016-721)

Establishment
Name	Address	ID/FEI	Business Operations
Accucaps Industries Limited Strathroy		243944050	analysis(68016-721) , manufacture(68016-721)

Establishment
Name	Address	ID/FEI	Business Operations
Legacy Pharmaceutical Packaging		969852743	pack(68016-721)