ALKA-SELTZER PLUS COLD AND FLU, CVP- chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet tablet, effervescent ALKA-SELTZER PLUS COLD AND FLU, BASIX- chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet tablet, effervescent ALKA-SELTZER PLUS COLD AND FLU- chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet tablet, effervescent

Alka-Seltzer Plus Cold and Flu by

Drug Labeling and Warnings

Alka-Seltzer Plus Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Lil' Drug Store Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Active ingredients (in each tablet)
Acetaminophen 250 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg

Purposes

Purposes
Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant

Uses

Uses

• temporarily relieves these symptoms due to a cold or flu:
• minor aches and pains
• headache
• cough
• sore throat
• runny nose
• sneezing
• nasal and sinus congestion
• temporarily reduces fever

Warnings

Liver warning

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

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

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 a 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
• a sodium restricted diet

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

Directions

• do not take more than the recommended dose
• adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 8 tablets in 24 hours or as directed by a doctor.
• children under 12 years: do not use

Other information

Other information

• each tablet contains: potassium 80 mg; sodium 356 mg
• store at room temperature. Avoid excessive heat.

Inactive ingredients

Inactive ingredients
anhydrous citric acid, calcium silicate, dimethicone, FD&C red #40, FD&C yellow #6, flavors, magnesium stearate, maltodextrin,
mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

Questions or comments?

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

SPL UNCLASSIFIED SECTION

DO NOT USE IF INNER POUCH OR CARTON IS OPEN OR DAMAGED!
PACKAGE NOT CHILD RESISTANT!

PDP/Package - Lil Drug Store

Alka-

Seltzer

Plus ®

CITRUS

FLAVOR

SEVERE Cold & Flu

POWERFAST FIZZ™

ACETAMINOPHEN/Pain Reliever-Fever Reducer

Chlorpheniramine Maleate/Antihistamine

Dextromethorphan HBr/Cough Suppressant

Phenylephrine Hydrochloride/Nasal Decongestant

• Fever & ​Body Ache
• Cough
• Nasal Congestion
• Runny Nose
• Sore Throat

4

Effervescent Tablets

[Lil' Drug Store logo]

PDP/Package - BASIX

Alka-

Seltzer

Plus ®

CITRUS

FLAVOR

SEVERE Cold & Flu

POWERFAST FIZZ™

ACETAMINOPHEN/Pain Reliever-Fever Reducer

Chlorpheniramine Maleate/Antihistamine

Dextromethorphan HBr/Cough Suppressant

Phenylephrine Hydrochloride/Nasal Decongestant

• Fever & ​Body Ache
• Cough
• Nasal Congestion
• Runny Nose
• Sore Throat

4

Effervescent Tablets

[TRAVEL

BASIX logo]

PDP/Package - Alka-Selter Plus Cold & Flu, CVP

Alka-

Seltzer

Plus ®

CITRUS

FLAVOR

SEVERE Cold & Flu

POWERFAST FIZZ™

ACETAMINOPHEN/Pain Reliever-Fever Reducer

Chlorpheniramine Maleate/Antihistamine

Dextromethorphan HBr/Cough Suppressant

Phenylephrine Hydrochloride/Nasal Decongestant

• Fever & ​Body Ache
• Cough
• Nasal Congestion
• Runny Nose
• Sore Throat

​

4

Effervescent Tablets

[CVP HEALTH logo]

Alka-Seltzer Plus Cold & Flu, 25ct Unit Dose Box

Alka-

Seltzer

PLUS ®

CITRUS

FLAVOR

SEVERE COLD & FLU

POWERFAST FIZZ™

ACETAMINOPHEN/Pain Reliever-Fever Reducer

Chlorpheniramine Maleate/Antihistamine

Dextromethorphan HBr/Cough Suppressant

Phenylephrine Hydrochloride/Nasal Decongestant

• Fever & ​Body Ache
• Cough
• Nasal Congestion
• Runny Nose
• Sore Throat

2 EFFERVESCENT TABLETS PER POUCH

​

Alka-Seltzer Plus Cold & Flu, 30ct Unit Dose Box

Alka-

Seltzer

PLUS ®

CITRUS

FLAVOR

SEVERE COLD & FLU

POWERFAST FIZZ™

ACETAMINOPHEN/Pain Reliever-Fever Reducer

Chlorpheniramine Maleate/Antihistamine

Dextromethorphan HBr/Cough Suppressant

Phenylephrine Hydrochloride/Nasal Decongestant

• Fever & ​Body Ache
• Cough
• Nasal Congestion
• Runny Nose
• Sore Throat

2 EFFERVESCENT TABLETS PER POUCH

INGREDIENTS AND APPEARANCE

ALKA-SELTZER PLUS COLD AND FLU, CVP 
chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet tablet, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-6531
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SUCRALOSE (UNII: 96K6UQ3ZD4)
CALCIUM SILICATE (UNII: S4255P4G5M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MANNITOL (UNII: 3OWL53L36A)

Product Characteristics
Color	white (speckled)	Score	no score
Shape	ROUND	Size	25mm
Flavor	CITRUS	Imprint Code	ASP;FLU
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66715-6531-2	2 in 1 CARTON	08/01/2022
1		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/25/2022

ALKA-SELTZER PLUS COLD AND FLU, BASIX 
chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet tablet, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-7831
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SUCRALOSE (UNII: 96K6UQ3ZD4)
CALCIUM SILICATE (UNII: S4255P4G5M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MANNITOL (UNII: 3OWL53L36A)

Product Characteristics
Color	white (speckled)	Score	no score
Shape	ROUND	Size	25mm
Flavor	CITRUS	Imprint Code	ASP;FLU
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66715-7831-2	2 in 1 CARTON	11/30/2022
1		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	11/30/2022

ALKA-SELTZER PLUS COLD AND FLU 
chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet tablet, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-9831
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SUCRALOSE (UNII: 96K6UQ3ZD4)
CALCIUM SILICATE (UNII: S4255P4G5M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MANNITOL (UNII: 3OWL53L36A)

Product Characteristics
Color	white (speckled)	Score	no score
Shape	ROUND	Size	25mm
Flavor	CITRUS	Imprint Code	ASP;FLU
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66715-9831-2	2 in 1 CARTON	04/25/2022
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 66715-9831-8	25 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product	04/27/2022
3	NDC: 66715-9831-9	30 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product	05/17/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/25/2022

Labeler - Lil' Drug Store Products, Inc. (093103646)