ALKA-SELTZER PLUS MULTI-SYMPTOM COLD AND FLU DAY AND NIGHT LIQUID GELS- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and Night by

Drug Labeling and Warnings

Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and Night 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 Multi Symptom Cold and Flu Day Liquigels

Drug Facts

Active Ingredients

Active ingredients

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg

Purpose

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal Decongestant

Uses

Uses

· 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

Warnings

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

· more than 4,000 mg of acetaminophen in 24 hours

· 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

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

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

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

When using this product

When using this product do not exceed recommended dosage

Stop use and ask a doctor

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

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

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

Directions

· 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

Other information
· store at room temperature. Avoid excessive heat above 40ºC

(104ºF).

Inactive Ingredients

Inactive ingredients

ferrosoferric oxide NF, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac purified, sorbitol-sorbitan solution

Questions or comments?

Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST)

SPL UNCLASSIFIED SECTION

Alka-Seltzer Plus® Multi-Symptom Cold & Flu Night Liquid Gels

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each capsule)

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine hydrochloride 5 mg

PURPOSE

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

Uses

· 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

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

· more than 4,000 mg of acetaminophen in 24 hours

· 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

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 DOCTOR

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 DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

● taking the blood thinning drug warfarin

● taking sedatives or tranquilizers

WHEN USING

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

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

Directions

· 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

Other information
· store at room temperature. Avoid excessive heat above 40ºC

(104ºF).

INACTIVE INGREDIENT

Inactive ingredients acacia gum, ascorbic acid, citric acid,

Dl-alpha-tocopherol, ferrosoferric oxide NF, gelatin, glycerin, maltodextrin, medium chain triglyceride oil, natural beta-carotene, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol-sorbitan solution, sunflower oil

Questions or Comments

Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALKA-SELTZER PLUS MULTI-SYMPTOM COLD AND FLU DAY AND NIGHT  LIQUID GELS
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0280-1138

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0280-1138-20	1 in 1 CARTON; Type 0: Not a Combination Product	07/15/2016	04/19/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BLISTER PACK	10
Part 2	1 BLISTER PACK	10

Part 1 of 2

ALKA-SELTZER PLUS  MULTI-SYMPTOM COLD AND FLU DAY LIQUID GELS
acetaminophen, dextromethorphan hbr, phenylephrine hcl 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
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN (UNII: 2G86QN327L)
WATER (UNII: 059QF0KO0R)
SHELLAC (UNII: 46N107B71O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)

Product Characteristics
Color	white (Clear)	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	FR;DC
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		10 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 not final	part343	07/01/2016	04/30/2019

Part 2 of 2

ALKA-SELTZER PLUS MULTI-SMPTOM COLD AND FLU NIGHT 
acetaminophen, dextromethorphan hbr, doxylamine sucinate, phenylephrine hcl 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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg

Inactive Ingredients
Ingredient Name	Strength
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCERIN (UNII: PDC6A3C0OX)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN (UNII: 2G86QN327L)
POVIDONE (UNII: FZ989GH94E)
.BETA.-CAROTENE (UNII: 01YAE03M7J)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SHELLAC (UNII: 46N107B71O)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	yellow (Light golden yellow)	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	FR;NC
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		10 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 not final	part343	07/01/2016	04/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	07/15/2016

Labeler - Bayer HealthCare LLC. (112117283)