Maximum Strength Sinus Relief  

Maximum Strength Sinus Relief  
SPL v1
SPL
SPL Set ID 0f2be061-bd0a-4e62-b994-6d0768ea647a
Route
ORAL
Published
Effective Date 2023-12-26
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 Blue No. 1 Fd&c Red No. 40 Gelatin, Unspecified Glycerin Polyethylene Glycol 400 Povidone K30 Propylene Glycol Water Sorbitol Sorbitan

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-25

Description

Drug Facts

Purpose

Pain reliever Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Pain reliever Cough suppressant Expectorant Nasal decongestant

Description

Drug Facts

Uses

• temporarily relieves:

• nasal congestion • headache • cough  • minor aches & pains • sinus congestion & pressure

• 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.

Section 42229-5

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

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

DAY TIME FOR AGES 12+

NIGHT TIME FOR AGES 12+

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

**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.

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

DISTRIBUTED BY

TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

Product of United Arab Emirates

REV.01-042023  CT7616282412

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

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 product

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 enlarged prostate gland  • 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 

When using these products  do not use more than directed.

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

Other Information

• store at 20-25°C (68-77°F)

• protect from light, heat and moisture

Inactive Ingredients

edible printing ink, FD&C Blue no. 1, FD&C Red no. 40, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, sorbitol sorbitan solution

Questions Or Comments?

Call: 1-888-423-0139

Maximum Strength** Sinus Relief Day

Drug Facts

Maximum Strength** Sinus Relief Night

Drug Facts

Active Ingredients (in Each Softgel) Day

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


Structured Label Content

Uses

• temporarily relieves:

• nasal congestion • headache • cough  • minor aches & pains • sinus congestion & pressure

• 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.

Section 42229-5 (42229-5)

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

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

DAY TIME FOR AGES 12+

NIGHT TIME FOR AGES 12+

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

**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.

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

DISTRIBUTED BY

TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

Product of United Arab Emirates

REV.01-042023  CT7616282412

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

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 product

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 enlarged prostate gland  • 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 

When using these products  do not use more than directed.

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

Other Information (Other information)

• store at 20-25°C (68-77°F)

• protect from light, heat and moisture

Inactive Ingredients (Inactive ingredients)

edible printing ink, FD&C Blue no. 1, FD&C Red no. 40, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, sorbitol sorbitan solution

Questions Or Comments? (Questions or comments?)

Call: 1-888-423-0139

Maximum Strength** Sinus Relief Day (MAXIMUM STRENGTH** Sinus Relief Day)

Drug Facts

Maximum Strength** Sinus Relief Night (MAXIMUM STRENGTH** Sinus Relief Night)

Drug Facts

Active Ingredients (in Each Softgel) Day (Active ingredients (in each softgel) DAY)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active Ingredients (in Each Softgel) Night (Active ingredients (in each softgel) NIGHT)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg


Advanced Ingredient Data


Raw Label Data

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