Search by Drug Name or NDC

NDC 63824-0250-01 Mucinex Sinus-Max 325; 10; 200; 5 mg/1; mg/1; ug/1; mg/1 Details

Mucinex Sinus-Max 325; 10; 200; 5 mg/1; mg/1; ug/1; mg/1

Mucinex Sinus-Max is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.

Product Information

NDC	63824-0250
Product ID	63824-250_64100c05-db8f-4750-96df-92bb3fe496d9
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Mucinex Sinus-Max
Proprietary Name Suffix	Pressure, Pain and Cough
Non-Proprietary Name	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	325; 10; 200; 5
Active Ingredient Units	mg/1; mg/1; ug/1; mg/1
Substance Name	ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	RB Health (US) LLC
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63824-0250-01 (63824025001)

Pricing Information	N/A
NDC Package Code	63824-250-01
Billing NDC	63824025001
Package	2 BLISTER PACK in 1 CARTON (63824-250-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date	2018-11-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8905706b-b9da-4520-8cf2-87d7c125edf3 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients (in each caplet)	Purposes
Acetaminophen 325 mg	Pain reliever
Dextromethorphan HBr 10 mg	Cough suppressant
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

temporarily relieves:
- nasal congestion
- headache
- minor aches and pains
- cough
- sinus congestion and 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

Warnings

Liver warning

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

more than 12 caplets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks daily while using this 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 an 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 this product 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 fever, rash, or headache that lasts. These could be signs of a serious condition.

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

Keep out of reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. 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

do not take more than directed (see Overdose warning)
do not take more than 12 caplets in any 24-hour period
adults and children 12 years of age and over: take 2 caplets every 4 hours
children under 12 years of age: do not use

Other information

store between 20-25°C (68-77°F)

Inactive ingredients

corn starch, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions?

1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Dist. by: Reckitt Benckiser

Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Carton

MAXIMUM STRENGTH

NDC 63824-250-01

Mucinex®

SINUS-MAX®

PRESSURE, PAIN & COUGH

Acetaminophen – Pain Reliever • Dextromethorphan HBr – Cough Suppressant

Guaifenesin – Expectorant • Phenylephrine HCl – Nasal Decongestant

✓: Relieves Sinus Pressure & Congestion
✓: Relieves Headache
✓: Controls Cough
✓: Thins & Loosens Mucus

FOR AGES 12+

20 CAPLETS

PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Carton

INGREDIENTS AND APPEARANCE

MUCINEX SINUS-MAX PRESSURE, PAIN AND COUGH

acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63824-250
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 ug
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Ingredient Name	Strength
Inactive Ingredients
starch, corn (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 2S7830E561)
FD&C red no. 40 (UNII: WZB9127XOA)
aluminum oxide (UNII: LMI26O6933)
FD&C yellow no. 6 (UNII: H77VEI93A8)
magnesium stearate (UNII: 70097M6I30)
maltodextrin (UNII: 7CVR7L4A2D)
microcrystalline cellulose (UNII: OP1R32D61U)
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)
polyvinyl alcohol, unspecified (UNII: 532B59J990)
povidone, unspecified (UNII: FZ989GH94E)
silicon dioxide (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
talc (UNII: 7SEV7J4R1U)
titanium dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	DCH
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63824-250-01	2 in 1 CARTON	11/15/2018
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	11/15/2018

Labeler - RB Health (US) LLC (081049410)

Revised: 1/2022

Document Id: 64100c05-db8f-4750-96df-92bb3fe496d9

Set id: 8905706b-b9da-4520-8cf2-87d7c125edf3

Version: 2

Effective Time: 20220127

Search by Drug Name or NDC

NDC 63824-0250-01 Mucinex Sinus-Max 325; 10; 200; 5 mg/1; mg/1; ug/1; mg/1 Details

Mucinex Sinus-Max 325; 10; 200; 5 mg/1; mg/1; ug/1; mg/1

Product Information

Package

Package Images

NDC 63824-0250-01 (63824025001)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 8905706b-b9da-4520-8cf2-87d7c125edf3 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Liver warning

Allergy alert

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Overdose warning

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Carton

INGREDIENTS AND APPEARANCE

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