- Label RSS
Drug Label Info
Safety
- Report Adverse Events
- FDA Safety Recalls
- Presence in Breast Milk
Related Resources
- Medline Plus
- Clinical Trials
- PubMed
- All Citations
- Adverse Effects
- Therapeutic Use
- Pharmacology
- Clinical Trials
- Biochemical Data Summary
More Info For This Drug
- View Labeling Archives
- RxNorm
- Get Label RSS Feed
- View NDC Code(s)NEW!
- NDC Code(s): 63868-587-20
- Packager: CHAIN DRUG MARKETING ASSOCIATION INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 13, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
View All Sections
- SPL UNCLASSIFIED SECTION
Drug Facts
- ACTIVE INGREDIENT
Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever Dextromethorphan HBr 10 mg Cough suppressant Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant - Uses
- temporarily relieves:
- headache
- nasal congestion
- minor aches and pains
- sinus congestion and pressure
- cough
- 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
- temporarily relieves:
- 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
- diabetes
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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 rash or headache that lasts
These could be signs of a serious condition.
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 (1-800-222-1222). 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 older: 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) in a dry place
- Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
- PRINCIPAL DISPLAY PANEL
NDC 63868-587-20
QUALITY CHOICE®
†Compare to the Active Ingredients in MUCINEX® Fast-Max® Pressure, Pain & Cough
Maximum Strength
Mucus Relief Sinus Pressure, Pain & Cough
Pain Reliever, Cough Suppressant, Expectorant, Nasal Decongestant
Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Relieves Sinus Pressure & Congestion
Relieves Headache
Controls Cough
Thins & Loosens Mucus
Actual Size
20 CAPLETS
- INGREDIENTS AND APPEARANCE
MUCUS RELIEF SINUS PRESSURE PAIN AND COUGH
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-587 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE, UNSPECIFIED (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) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) 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 AAA;1165 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-587-20 2 in 1 CARTON 12/01/2020 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/01/2020 Labeler -CHAIN DRUG MARKETING ASSOCIATION INC(011920774)
View All Sections
Find additional resources
(also available in the left menu)
Safety
Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk
Related Resources
Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary
More Info on this Drug
View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!
View Labeling Archives for this drug
MUCUS RELIEF SINUS PRESSURE PAIN AND COUGH- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, coated
Number of versions: 2
Published Date (What is this?) | Version | Files |
---|---|---|
Dec 19, 2022 | 3 (current) | download |
Dec 8, 2020 | 2 | download |
RxNorm
MUCUS RELIEF SINUS PRESSURE PAIN AND COUGH- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, coated
RxCUI | RxNorm NAME | RxTTY | |
---|---|---|---|
1 | 1110988 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN |
2 | 1110988 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD |
3 | 1110988 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY |
Get Label RSS Feed for this Drug
MUCUS RELIEF SINUS PRESSURE PAIN AND COUGH- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, coated
To receive this label RSS feed
Copy the URL below and paste it into your RSS Reader application.
https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=3d068d30-9a00-49d7-bbe9-d6b53c19e86d
To receive all DailyMed Updates for the last seven days
Copy the URL below and paste it into your RSS Reader application.
https://dailymed.nlm.nih.gov/dailymed/rss.cfm
What will I get with the DailyMed RSS feed?
DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.
DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X.
How to discontinue the RSS feed
If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader.
Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages?
Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels.
We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels.
NDC Codes
MUCUS RELIEF SINUS PRESSURE PAIN AND COUGH- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, coated
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
NDC | |
---|---|
1 | 63868-587-20 |