Maximum Strength** Sinus Relief Day And Night Softgels

Maximum Strength** Sinus Relief Day And Night Softgels
SPL v2
SPL
SPL Set ID a7285fe0-5a5b-42c4-be47-9a07a2ba75e8
Route
ORAL
Published
Effective Date 2025-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Guaifenesin (200 mg) Phenylephrine (5 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Fd&c Yellow No. 6 Gelatin, Unspecified Glycerin Polyethylene Glycol, Unspecified Povidone, Unspecified Propylene Glycol Sorbitol Sorbitan Titanium Dioxide D&c Yellow No. 10 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-13

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg Active ingredients (in each softgel) NIGHT ​ Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever Cough suppressant Expectorant Nasal decongestant Purposes Pain reliever Cough suppressant Antihistamine Nasal decongestant


Medication Information

Purpose

Pain reliever Cough suppressant Expectorant Nasal decongestant Purposes Pain reliever Cough suppressant Antihistamine Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg Active ingredients (in each softgel) NIGHT ​ Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg

Uses

• temporarily relieves:

  • nasal congestion          • headache      • cough 

  • minor aches & pains     • sinus congestion & pressure

  • runny nose and sneezing  (NIGHT only)

• temporarily promotes nasal and/or sinus drainage

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY only)

Section 42229-5

TopCare ® health

COMPARE TO MUCINEX® SINUS-MAX® DAY ACTIVE INGREDIENTS*

COMPARE TO MUCINEX® SINUS-MAX® NIGHT ACTIVE INGREDIENTS*

MAXIMUM STRENGTH**

*These products are not manufactured or distributed by Reckitt Benckiser, distributor of Mucinex® Sinus-Max® Day & Night Softgel

QUALITY GUARANTEED

This TopCare® product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed.

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ITASCA, IL 60143

©TOPCO STVA0925

[email protected] 

www.topcarebrand.com

PRODUCT OF INDIA

**Per 4-hour dose.

Do not take DAY & NIGHT softgels at the same time. Do not take more than a total of 12 softgels in a 24-hour period. Do not take the first dose of the NIGHT softgels sooner than 4 hours after the last dose of the DAY softgels unless directed by a doctor.

Take only as directed.

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

Section 50565-1

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. 

Purposes

Pain reliever

Cough suppressant

Expectorant

Nasal decongestant

Purposes

Pain reliever

Cough suppressant

Antihistamine

Nasal decongestant

Warnings

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

• more than 12 softgels in 24 hours, which is the maximum daily amount 

• with other drugs containing acetaminophen 

• 3 or more alcoholic drinks every day while using these products

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: 

• skin reddening  • blisters  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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.

Ask a doctor before use if you have

• liver disease            • heart disease     • diabetes

• high blood pressure  • thyroid disease  

• trouble urinating due to an enlarged prostate gland

• glaucoma (NIGHT only)

a breathing problem such as emphysema or chronic bronchitis (NIGHT only)

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

• cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

• taking sedatives or tranquilizers (NIGHT only)

When using these products

do not use more than directed

• excitability may occur, especially in children (NIGHT only)

• marked drowsiness may occur (NIGHT only)

• alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT only)

• avoid alcoholic drinks (NIGHT only)

• be careful when driving a motor vehicle or operating machinery (NIGHT only)

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occur

• pain, nasal congestion, or cough 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.

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

Packaging

Directions

• do not take more than directed (see Overdose warning)

• do not take more than 12 softgels in any 24-hour period

• adults and children 12 years of age and older: take 2 softgels every 4 hours

• children under 12 years of age: do not use

Drug Facts

Other Information

• store at controlled room temperature between 20-25°C (68-77°F)

• protect from light, heat and moisture

Active Ingredients 

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active ingredients (in each softgel) NIGHT

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Questions Or Comments?

1-888-423-0139

Inactive Ingredients (day Only)

FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide

Inactive ingredients (NIGHT only)

D&C Yellow No.10, FD&C Blue No.1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide


Structured Label Content

Uses

• temporarily relieves:

  • nasal congestion          • headache      • cough 

  • minor aches & pains     • sinus congestion & pressure

  • runny nose and sneezing  (NIGHT only)

• temporarily promotes nasal and/or sinus drainage

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY only)

Section 42229-5 (42229-5)

TopCare ® health

COMPARE TO MUCINEX® SINUS-MAX® DAY ACTIVE INGREDIENTS*

COMPARE TO MUCINEX® SINUS-MAX® NIGHT ACTIVE INGREDIENTS*

MAXIMUM STRENGTH**

*These products are not manufactured or distributed by Reckitt Benckiser, distributor of Mucinex® Sinus-Max® Day & Night Softgel

QUALITY GUARANTEED

This TopCare® product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed.

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ITASCA, IL 60143

©TOPCO STVA0925

[email protected] 

www.topcarebrand.com

PRODUCT OF INDIA

**Per 4-hour dose.

Do not take DAY & NIGHT softgels at the same time. Do not take more than a total of 12 softgels in a 24-hour period. Do not take the first dose of the NIGHT softgels sooner than 4 hours after the last dose of the DAY softgels unless directed by a doctor.

Take only as directed.

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

Section 50565-1 (50565-1)

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. 

Purposes

Pain reliever

Cough suppressant

Expectorant

Nasal decongestant

Purposes

Pain reliever

Cough suppressant

Antihistamine

Nasal decongestant

Warnings

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

• more than 12 softgels in 24 hours, which is the maximum daily amount 

• with other drugs containing acetaminophen 

• 3 or more alcoholic drinks every day while using these products

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: 

• skin reddening  • blisters  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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.

Ask a doctor before use if you have

• liver disease            • heart disease     • diabetes

• high blood pressure  • thyroid disease  

• trouble urinating due to an enlarged prostate gland

• glaucoma (NIGHT only)

a breathing problem such as emphysema or chronic bronchitis (NIGHT only)

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

• cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

• taking sedatives or tranquilizers (NIGHT only)

When using these products

do not use more than directed

• excitability may occur, especially in children (NIGHT only)

• marked drowsiness may occur (NIGHT only)

• alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT only)

• avoid alcoholic drinks (NIGHT only)

• be careful when driving a motor vehicle or operating machinery (NIGHT only)

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occur

• pain, nasal congestion, or cough 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.

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

Packaging

Directions

• do not take more than directed (see Overdose warning)

• do not take more than 12 softgels in any 24-hour period

• adults and children 12 years of age and older: take 2 softgels every 4 hours

• children under 12 years of age: do not use

Drug Facts

Other Information (Other information)

• store at controlled room temperature between 20-25°C (68-77°F)

• protect from light, heat and moisture

Active Ingredients  (Active ingredients )

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active ingredients (in each softgel) NIGHT

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Questions Or Comments? (Questions or comments?)

1-888-423-0139

Inactive Ingredients (day Only) (Inactive ingredients (DAY only))

FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide

Inactive ingredients (NIGHT only)

D&C Yellow No.10, FD&C Blue No.1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide


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