SEVERE COLD PLUS FLU DAYTIME NIGHTTIME- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and doxylamine succinate kit

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

SEVERE COLD + FLU DAYTIME

Drug Facts

Active ingredients (in each packet)	Purposes
Acetaminophen 500 mg	Pain reliever/fever reducer
Dextromethorphan hydrobromide 20 mg	Cough suppressant
Guaifenesin 400 mg	Expectorant
Phenylephrine hydrochloride 10 mg	Nasal decongestant

Uses
- ▪ temporarily relieves these symptoms due to a cold or flu:
  - ▪ minor aches and pains
  - ▪ headache
  - ▪ sore throat
  - ▪ cough
  - ▪ nasal congestion
  - ▪ sinus congestion and pressure
- ▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
- ▪ temporarily reduces fever
Warnings
Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take
- ▪ more than 6 packets 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
- Is 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
- ▪ difficulty in urination due to enlargement of the prostate gland
- ▪ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- ▪ cough with excessive phlegm (mucus)
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 at 1-800-222-1222. 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 the recommended dose
- ▪ take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor
- ▪ adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
- ▪ children under 12 years: do not use
Other information
- ▪ each packet contains: potassium 6 mg
- ▪ store at room temperature
Inactive ingredients

anhydrous citric acid, flavors, maltodextrin, potassium citrate, silica, sucralose, sucrose, yellow#6
Questions or comments?

1-866-467-2748
SPL UNCLASSIFIED SECTION

SEVERE COLD + FLU NIGHTTIME

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each packet)	Purposes
Acetaminophen 650 mg	Pain reliever/fever reducer
Dextromethorphan hydrobromide 20 mg	Cough suppressant
Doxylamine succinate 12.5 mg	Antihistamine
Phenylephrine hydrochloride 10 mg	Nasal decongestant

Uses
- ▪ temporarily relieves these symptoms due to a cold or flu:
  - ▪ headache
  - ▪ minor aches and pains
  - ▪ cough
  - ▪ sore throat
  - ▪ nasal congestion
  - ▪ sinus congestion and pressure
  - ▪ runny nose
  - ▪ sneezing
- ▪ temporarily reduces fever
Warnings
Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take
- ▪ more than 5 packets 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 reactions. Symptoms may include:
- ▪ Skin reddening
- ▪ Blisters
- ▪ Rash
- ▪ Hives
- ▪ facial swelling
- ▪ asthma (wheezing)
- ▪ shock
Is 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 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 at 1-800-222-1222. 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 the recommended dose
- ▪ take every 4 hours; do not exceed 5 packets in 24 hours or as directed by a doctor
- ▪ adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
- ▪ children under 12 years: do not use
Other information
- ▪ each packet contains: potassium 6 mg
- ▪ store at room temperature
Inactive ingredients

anhydrous citric acid, flavors, maltodextrin, potassium citrate, silica, sucralose, sucrose, yellow#6
Questions or comments?

1-866-467-2748
PRINCIPAL DISPLAY PANEL-

Compare to Alka-Seltzer PLUS® Severe Cold +Flu Day and Night Active Ingredients*

DAYTIME

SEVERE COLD & FLU

Acetaminophen / Pain reliever-fever reducer

Dextromethorphan HBr / Cough suppressant

Guaifenesin / Expectorant
Phenylephrine HCl / Nasal decongestant

Relieves:
Nasal Congestion Headache
Sore Throat Body Ache Cough
Mucus Chest Congestion Fever

Honey Lemon Flavor

Naturally and Artificially Flavored

NIGHTTIME

Severe Cold & Flu

Acetaminophen / Pain reliever-fever reducer

Dextromethorphan HBr / Cough suppressant
Doxylamine succinate / Antihistamine
Phenylephrine HCl / Nasal decongestant

Relieves:

Nasal Congestion Headache
Sore Throat Body Ache
Cough Runny Nose Fever

Honey Lemon Flavor

Naturally and Artificially Flavored

TAMPER EVIDENT: DO NOT USE IF INDIVIDUAL POUCH IS TORN OR OPEN

DO NOT TAKE THESE PRODUCTS AT THE SAME TIME

6 DAY PACKETS + 6 NIGHT PACKETS
12 TOTAL

Distributed by: CVS Pharmacy, Inc.

One CVS Drive Woonsocket, RI 02895

©2017 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

Money Back Guarantee

*These products is not manufactured or distributed by Bayer Healthcare, LLC, distributor of Alka-Seltzer plus® Severe Cold +Flu Day and Night.

INGREDIENTS AND APPEARANCE

SEVERE COLD PLUS FLU DAYTIME NIGHTTIME
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-546

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 69842-546-12	1 in 1 CARTON; Type 0: Not a Combination Product	07/14/2017

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 CARTON	6
Part 2	1 CARTON	6

Part 1 of 2

SEVERE COLD PLUS FLU DAYTIME
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride powder, for solution

Product Information
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		6 in 1 CARTON; 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	07/14/2017

Part 2 of 2

SEVERE COLD PLUS FLU NIGHTTIME
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride powder, for solution

Product Information
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		6 in 1 CARTON; 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	07/14/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	07/14/2017

Labeler - CVS Pharmacy,Inc. (062312574)

SEVERE COLD PLUS FLU DAYTIME NIGHTTIME- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and doxylamine succinate kit

SEVERE COLD PLUS FLU DAYTIME NIGHTTIME by

Drug Labeling and Warnings

Drug Details [pdf]

Liver warning

ALLERGY ALERT

Sore throat warning

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if