ALKA-SELTZER PLUS DAY AND NIGHT SEVERE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and doxylamine succinate kit

Alka-Seltzer Plus Day and Night Severe Cold and Flu by

Drug Labeling and Warnings

Alka-Seltzer Plus Day and Night Severe Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Alka-Seltzer Plus ®
Severe Cold + Flu Day

Drug Facts

ACTIVE INGREDIENT

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

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. 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 5 mg and sodium 6 mg
• store at room temperature

Inactive ingredients

acesulfame potassium, anhydrous citric acid, compressible sugar, D&C yellow #10, dental-type silica, FD&C red #40, flavors, maltodextrin, povidone, pregelatinized starch, silicon dioxide, sodium citrate, stearic acid, sucralose, tartaric acid, tribasic calcium phosphate

Questions or comments?

1-800-986-0369 (Mon-Fri 9AM - 5PM EST)

SPL UNCLASSIFIED SECTION

Alka-Seltzer Plus ®
Severe Cold + Flu Night

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

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. 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 5 mg and sodium 5 mg
• store at room temperature

Inactive ingredients

acesulfame potassium, anhydrous citric acid, compressible sugar, D&C yellow #10, dental-type silica, FD&C red #40, flavors, pregelatinized starch, sodium citrate, sucralose, tartaric acid, tribasic calcium phosphate

Questions or comments?

1-800-986-0369 (Mon-Fri 9AM - 5PM EST)

SPL UNCLASSIFIED SECTION

Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - Kit Carton

Alka-Seltzer
PLUS ®

SEVERE COLD + FLU

Honey Lemon Zest
Fast Relief Mix-In Packets

DAYNON-DROWSY

Acetaminophen / Pain reliever-fever reducer

Phenylephrine HCl / Nasal decongestant

Dextromethorphan HBr / Cough suppressant

Guaifenesin / Expectorant

Nasal Congestion

Headache & Body Ache
Cough Sore Throat Mucus

Fever Chest Congestion

NIGHT

Acetaminophen / Pain reliever-fever reducer

Doxylamine succinate / Antihistamine

Phenylephrine HCl / Nasal decongestant

Dextromethorphan HBr / Cough suppressant

Nasal Congestion

Headache & Body Ache
Cough Runny Nose
Fever Sore Throat

6 DAY PACKETS + 6 NIGHT PACKETS

12 TOTAL

INGREDIENTS AND APPEARANCE

ALKA-SELTZER PLUS DAY AND NIGHT SEVERE COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0280-0924

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0280-0924-12	1 in 1 CARTON; Type 0: Not a Combination Product	07/01/2014

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

Part 1 of 2

ALKA-SELTZER PLUS DAY SEVERE COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride powder, for solution

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
HONEY (UNII: Y9H1V576FH)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TARTARIC ACID (UNII: W4888I119H)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
SUCROSE (UNII: C151H8M554)
MENTHOL (UNII: L7T10EIP3A)
LEMON (UNII: 24RS0A988O)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor	LEMON, HONEY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 PACKET; 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	07/01/2014

Part 2 of 2

ALKA-SELTZER PLUS NIGHT SEVERE COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride powder, for solution

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C RED NO. 40 (UNII: WZB9127XOA)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TARTARIC ACID (UNII: W4888I119H)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
SUCROSE (UNII: C151H8M554)
MENTHOL (UNII: L7T10EIP3A)
LEMON (UNII: 24RS0A988O)
HONEY (UNII: Y9H1V576FH)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor	HONEY, LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 PACKET; 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	07/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/01/2014

Labeler - Bayer HealthCare LLC. (112117283)