Indications and uses
temporarily relieves these common cold and flu symptoms: nasal congestion cough headache minor aches and pains sinus congestion and pressure temporarily reduces fever temporarily promotes nasal and/or sinus drainage
Mucinex Fast-Max
- Manufacturer
- Reckitt Benckiser LLC
- Effective date
- 2017-04-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:16:37
Label at a glance#
ProductMucinex Fast-Max Severe Cold and Sinus
Active ingredientAcetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
Label structure10 sections
Dosage and administration
do not take more than directed (see Overdose warning ) do not take more than 12 liquid gels in any 24-hour period adults and children 12 years of age and older: take 2 liquid gels every 4 hours children under 12 years of age: do not use
Storage and handling
store between 20-25°C (68-77°F) avoid excessive heat
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredients (in each liquid gel) | Purposes |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
Uses
- temporarily relieves these common cold and flu symptoms:
- nasal congestion
- cough
- headache
- minor aches and pains
- sinus congestion and pressure
- temporarily reduces fever
- temporarily promotes nasal and/or sinus drainage
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 12 liquid gels 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.
OTC - DO NOT USE SECTION
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.
OTC - ASK DOCTOR SECTION
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, or emphysema
- cough that occurs with too much phlegm (mucus)
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
OTC - WHEN USING SECTION
When using this product do not use more than directed
OTC - STOP USE SECTION
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 liquid gels in any 24-hour period
- adults and children 12 years of age and older: take 2 liquid gels every 4 hours
- children under 12 years of age: do not use
Other information
- store between 20-25°C (68-77°F)
- avoid excessive heat
Inactive ingredients
FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, lecithin (soy), mineral oil, polyethylene glycol, povidone, propylene glycol, sorbitol, titanium dioxide, water
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
Made in China
PRINCIPAL DISPLAY PANEL - 16 Liquid Gels Blister Pack Carton
Fast Dissolving Liquid Gels!
MAXIMUM STRENGTH*
NDC 63824-592-16
Mucinex®
FAST-MAX®
SEVERE COLD
& SINUS
NEW!
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Phenylephrine HCl – Nasal Decongestant
- Relieves Headache & Fever
- Controls Cough
- Relieves Nasal Congestion
16
LIQUID GELS
(Liquid Filled Capsules)
NON-DROWSY
FOR AGES 12+
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63824-592-16 | 2023-09-07 | C162847 | 48780-1 | 9d75b9d0-5671-f424-e053-dadaa90a57ce | Mucinex® Fast-Max ® Severe Cold & Sinus |
| 63824-592-16 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-5671-f424-e053-dadaa90a57ce | Mucinex® Fast-Max ® Severe Cold & Sinus |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63824-592-16 | EA - Each | 63824-592 | 3a75b1dc-4cc3-4d5f-923d-1f581b0e0548 | 1 | 2015-08-04 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Acetaminophen | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| Dextromethorphan hydrobromide | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| Phenylephrine hydrochloride | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| Acetaminophen | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| Dextromethorphan | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| Phenylephrine | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| FD&C red no. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| FD&C yellow no. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| gelatin | INACTIVE INGREDIENT | 2G86QN327L | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| lecithin, soybean | INACTIVE INGREDIENT | 1DI56QDM62 | 1 | |
| mineral oil | INACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| povidones | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| sorbitol | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Mucinex Fast-Max Severe Cold and Sinus
- Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride
- Acetaminophen
- Dextromethorphan hydrobromide
- Dextromethorphan
- Phenylephrine hydrochloride
- Phenylephrine
- FD&C red no. 40
- FD&C yellow no. 6
- gelatin, unspecified
- glycerin
- lecithin, soybean
- mineral oil
- polyethylene glycol, unspecified
- povidone, unspecified
- propylene glycol
- sorbitol
- titanium dioxide
- water
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63824-592 | 63824-592-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| sorbitol | SORBITOL | 506T60A25R | OINTMENT / TOPICAL | 10 %w/w | ||
| gelatin | GELATIN | 2G86QN327L | INJECTION / INTRACAVITARY | 0.05 ml | ||
| glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| sorbitol | SORBITOL | 506T60A25R | SOLUTION / ORAL | 29268 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| FD&C yellow no. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, DELAYED RELEASE / ORAL | 0.02 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY, METERED / NASAL | 240 mg | ||
| sorbitol | SORBITOL | 506T60A25R | SPRAY / NASAL | 49 mg | ||
| mineral oil | MINERAL OIL | T5L8T28FGP | SYSTEM / TRANSDERMAL | 6.09 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | SHAMPOO / TOPICAL | 2 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / DENTAL | NA | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / ORAL | 2 mg | ||
| mineral oil | MINERAL OIL | T5L8T28FGP | FILM / TRANSDERMAL | 11.42 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CONCENTRATE / ORAL | 7000 mg | ||
| povidones | POVIDONE | FZ989GH94E | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 350 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| sorbitol | SORBITOL | 506T60A25R | ELIXIR / ORAL | 833.3 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | DOUCHE / VAGINAL | 1 %w/w | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | FILM / BUCCAL | 3 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO / TOPICAL | 8 %w/w | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM / BUCCAL | 1.48 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| povidones | POVIDONE | FZ989GH94E | IMPLANT / SUBCUTANEOUS | 6 mg | ||
| gelatin | GELATIN | 2G86QN327L | WAFER / ORAL | NA | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, COATED / ORAL | 16 mg | ||
| sorbitol | SORBITOL | 506T60A25R | GUM, CHEWING / ORAL | 6168 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| povidones | POVIDONE | FZ989GH94E | SOLUTION / ORAL | 3000 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / ORAL | 2 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | DROPS / ORAL | 200 mg/1ml | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, COATED / ORAL | 0.1 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO, SUSPENSION / TOPICAL | 2 %w/w | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, DELAYED RELEASE / ORAL | 1.7 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / TOPICAL | 5148 mg | ||
| povidones | POVIDONE | FZ989GH94E | CAPSULE / ORAL | 300 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL / TOPICAL | 19.2 %w/w | ||
| sorbitol | SORBITOL | 506T60A25R | PASTE, DENTIFRICE / DENTAL | 14 %w/w | ||
| mineral oil | MINERAL OIL | T5L8T28FGP | DROPS / ORAL | NA | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / RECTAL | 27 mg | ||
| mineral oil | MINERAL OIL | T5L8T28FGP | LOTION / TOPICAL | 1428 mg | ||
| sorbitol | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / OPHTHALMIC | 1 %w/v | ||
| sorbitol | SORBITOL | 506T60A25R | CREAM, AUGMENTED / TOPICAL | 15 %w/w | ||
| gelatin | GELATIN | 2G86QN327L | TABLET, ORALLY DISINTEGRATING / SUBLINGUAL | 13 mg | ||
| FD&C yellow no. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, FILM COATED / ORAL | 1 mg | ||
| FD&C yellow no. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, DELAYED RELEASE / ORAL | 2 mg | ||
| sorbitol | SORBITOL | 506T60A25R | INJECTION / INTRASYNOVIAL | 45 %w/v | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUPPOSITORY / VAGINAL | 252 mg | ||
| mineral oil | MINERAL OIL | T5L8T28FGP | CAPSULE, EXTENDED RELEASE / ORAL | 120 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | SPONGE / TOPICAL | NA | ||
| sorbitol | SORBITOL | 506T60A25R | INJECTION / INTRAVENOUS | 1276 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| lecithin, soybean | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET, EXTENDED RELEASE / ORAL | 20 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| gelatin | GELATIN | 2G86QN327L | TABLET, SUGAR COATED / ORAL | NA | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAVENOUS | 4000 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 017e5dc2-18e3-1670-e063-6294a90a3ce8 | aa68b8de-1649-413d-b0d9-77d2ca83d5a9 | 2023-07-27 | Warnings | aa68b8de-1649-413d-b0d9-77d2ca83d5a9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.