CVS HEALTH NON DROWSY DAY COLD AND FLU PLUS AND NIGHTTIME COLD AND FLU PLUS- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit

CVS Health Non Drowsy DAY Cold and Flu Plus and NIGHTTIME Cold and Flu Plus by

Drug Labeling and Warnings

CVS Health Non Drowsy DAY Cold and Flu Plus and NIGHTTIME Cold and Flu Plus by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

 CVS Health COLD & FLU FORMULA DAY NON-DROWSY Active ingredients (in each softgel)

Acetaminophen 325 mg 
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg

CVS Health COLD & FLU FORMULA NIGHT Active ingredients (in each softgel)

Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine hydrochloride 5 mg

Purposes

DAY COLD & FLU FORMULA

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Purposes

NIGHT COLD & FLU FORMULA

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

DAY COLD & FLU FORMULA

• 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 COLD & FLU FORMULA

• 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

DAY COLD & FLU FORMULA Warnings 

Liver warning

These products contain acetaminophen. Severe liver damage may occur if you take

• more than 10 softgels 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.

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.
• 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 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.

NIGHTTIME COLD & FLU FORMULA Warnings

Liver warning

These products contain acetaminophen. Severe liver damage may occur if you take

• more than 10 softgels 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.

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 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 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.

DAY COLD & FLU FORMULA Directions

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

NIGHTTIME COLD & FLU FORMULA Directions

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

DAY COLD & FLU FORMULA Other information

• store at room temperature. Avoid excessive heat.

NIGHTTIME COLD & FLU FORMULA Other information

• store at room temperature. Avoid excessive heat.

DAY COLD & FLU FORMULA Inactive ingredients 

FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene
glycol-400, povidone, propylene glycol, purified water, sorbitol sorbitan,
titanium dioxide

NIGHTTIME COLD & FLU FORMULA Inactive ingredients 

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene
glycol-400, povidone, propylene glycol, purified water, shellac, sorbitol
sorbitan, sodium hydroxide, titanium dioxide

DAY COLD & FLU FORMULA

Questions or comments?1-888-333-9792

NIGHTTIME COLD & FLU FORMULA

Questions or comments?1-888-333-9792

Principal Display Panel

CVS NON-DROWSY DAY Cold & Flu Plus and NIGHTTIME Cold & Flu Plus 20ct

Compare to the active ingredients in
Alka-Seltzer PLUS® Day and Night Cold and Flu Formula

NON-DROWSY DAY

Cold & Flu Plus
ACETAMINOPHEN- Pain reliever; Fever reducer
DEXTROMETHORPHAN HBr - Cough suppressant
PHENYLEPHRINE HCI - Nasal decongestant
Relieves:
Nasal congestion; Cough;
Headache & body ache;
Sore throat; Sinus pressure

12 SOFTGELS

NIGHTTIME

Cold & Flu Plus

ACETAMINOPHEN- Pain reliever; Fever reducer
DEXTROMETHORPHAN HBr - Cough suppressant
DOXYLAMINE SUCCINATE - Antihistamine
PHENYLEPHRINE HCI - Nasal decongestant
Relieves:
Nasal congestion; Cough;
Headache & body ache;
Sore throat; Runny nose
8 SOFTGELS

THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND
TAMPER-EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT

*This product is not manufactured or distributed by Bayer
Healthcare LLC, owner of the registered trademark
Alka-Seltzer PLUS® Day and Night Cold and Flu Formula

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2019 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
Made in India
V-35249

INGREDIENTS AND APPEARANCE

CVS HEALTH NON DROWSY DAY COLD AND FLU PLUS AND NIGHTTIME COLD AND FLU PLUS 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-517

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-517-20	1 in 1 CARTON; Type 0: Not a Combination Product	06/05/2019

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

CVS HEALTH DAY COLD AND FLU 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	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 GLYCOL 400 (UNII: B697894SGQ)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange (transparent)	Score	no score
Shape	CAPSULE (oblong)	Size	21mm
Flavor		Imprint Code	512
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	06/05/2019

Part 2 of 2

CVS HEALTH NIGHTTIME COLD AND FLU PLUS 
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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 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 400 (UNII: B697894SGQ)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SHELLAC (UNII: 46N107B71O)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	green (transparent)	Score	no score
Shape	CAPSULE (oblong)	Size	21mm
Flavor		Imprint Code	116
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 CARTON
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	06/05/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/05/2019

Labeler - CVS Pharmacy (062312574)

Registrant - Spirit Pharmaceuticals LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
MEDGEL PRIVATE LTD		677385498	manufacture(69842-517)