Cvs Health Maximum Strength Non Drowsy Day And Night Cold And Flu Max Softgels Minis

Cvs Health Maximum Strength Non Drowsy Day And Night Cold And Flu Max Softgels Minis
SPL v8
SPL
SPL Set ID 1b67bc67-ddd2-4b37-a9a4-c3119433e231
Route
ORAL
Published
Effective Date 2019-06-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Gelatin Glycerin Polyethylene Glycol 400 Sorbitan Sorbitol Titanium Dioxide Food Yellow 3 Free Acid Water Povidone Propylene Glycol Fd&c Blue No. 1 D&c Yellow No. 10

Identifiers & Packaging

Pill Appearance
Imprint: 102 Shape: oval Color: orange Color: green Size: 18 mm Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-06-06

Description

Do not take these products at the same time.


Medication Information

Warnings and Precautions

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.

Description

Do not take these products at the same time.

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

Section 42229-5

Drug Facts

Section 42230-3

Do not take these products at the same time.

Section 50565-1

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.

Section 50566-9

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

Section 50567-7

When using this product do not exceed recommended dosage

Section 50568-5

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

Section 50569-3

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

Section 50570-1

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

Section 51727-6

Inactive ingredients

FD&C yellow #6, gelatin,

glycerin, pearlin silver, polyethylene glycol, povidone,

propylene glycol, purified water, sorbitol , titanium

dioxide

Section 51945-4

CVS Health

MAXIMUM STRENGTH

COLD & FlU MAX SOFTGELS

Compare to the active ingredients in



Alka-Seltzer PLUS® Maximum Strength Day



and Night Cold and Flu POWERMAX™ GELS

DAY NON DROWSY

Acetaminophen / Pain Reliever-Fever Reducer

Dextromethorphan HBr / Cough Suppressant

Phenylephrine HCl / Nasal Decongestant

Relieves:

Nasal Congestion



Headache & Body Ache



Cough



Sore Throat



Sinus Pressure

16 SOFTGELS

NIGHT TIME

Acetaminophen / Pain Reliever-Fever Reducer

Dextromethorphan HBr / Cough Suppressant

Doxylamine Succinate / Antihistamine

Phenylephrine HCl / Nasal Decongestant

Nasal Congestion



Headache & Body Ache



Cough



Runny Nose



Sore Throat



8 SOFTGELS

24 SOFTGELS TOTAL

*This product is not manufactured or distributed by Bayer



HealthCare LLC, owner of the registered trademark



Alka-Seltzer PLUS® POWERMAX™ GELS.

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

Section 53414-9

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

Section 55105-1

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Section 55106-9

Active ingredients (in each capsule)

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg

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 temperatures above 25°C (77°F).

Questions Or Comments?

Questions or comments? 1-888-333-9792


Structured Label Content

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 and Precautions (34071-1)

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.

Section 42229-5 (42229-5)

Drug Facts

Section 42230-3 (42230-3)

Do not take these products at the same time.

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product do not exceed recommended dosage

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients

FD&C yellow #6, gelatin,

glycerin, pearlin silver, polyethylene glycol, povidone,

propylene glycol, purified water, sorbitol , titanium

dioxide

Section 51945-4 (51945-4)

CVS Health

MAXIMUM STRENGTH

COLD & FlU MAX SOFTGELS

Compare to the active ingredients in



Alka-Seltzer PLUS® Maximum Strength Day



and Night Cold and Flu POWERMAX™ GELS

DAY NON DROWSY

Acetaminophen / Pain Reliever-Fever Reducer

Dextromethorphan HBr / Cough Suppressant

Phenylephrine HCl / Nasal Decongestant

Relieves:

Nasal Congestion



Headache & Body Ache



Cough



Sore Throat



Sinus Pressure

16 SOFTGELS

NIGHT TIME

Acetaminophen / Pain Reliever-Fever Reducer

Dextromethorphan HBr / Cough Suppressant

Doxylamine Succinate / Antihistamine

Phenylephrine HCl / Nasal Decongestant

Nasal Congestion



Headache & Body Ache



Cough



Runny Nose



Sore Throat



8 SOFTGELS

24 SOFTGELS TOTAL

*This product is not manufactured or distributed by Bayer



HealthCare LLC, owner of the registered trademark



Alka-Seltzer PLUS® POWERMAX™ GELS.

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredients (in each capsule)

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg

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)

Other information

● store at room temperature. Avoid temperatures above 25°C (77°F).

Questions Or Comments? (Questions or comments?)

Questions or comments? 1-888-333-9792


Advanced Ingredient Data


Raw Label Data

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