Label: MUCINEX FAST-MAX DAY TIME SEVERE COLD AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH- acetaminophen, dextromethorphan hydrobromide, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride kit
- NDC Code(s): 63824-551-30
- Packager: RB Health (US) LLC
- 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 January 13, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- ACTIVE INGREDIENT
-
Uses
- temporarily relieves these common cold and flu symptoms:
- nasal congestion
- cough (Mucinex FAST-MAX DAY TIME Severe Cold only)
- minor aches and pains
- headache
- sore throat
- runny nose and sneezing (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Mucinex FAST-MAX DAY TIME Severe Cold only)
- temporarily reduces fever
- temporarily relieves these common cold and flu symptoms:
-
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 that contain acetaminophen
- 3 or more alcoholic drinks daily while using this product
Sore throat warning
if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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.
- with any other drug containing diphenhydramine, even one used on the skin (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
- 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.
- for children under 12 years of age
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- glaucoma (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
- a breathing problem such as emphysema or chronic bronchitis (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (Mucinex FAST-MAX DAY TIME Severe Cold only)
- cough that occurs with too much phlegm (mucus) (Mucinex FAST-MAX DAY TIME Severe Cold only)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
When using this product
- do not use more than directed
- excitability may occur, especially in children (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
- marked drowsiness may occur (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
- avoid alcoholic drinks (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
- be careful when driving a motor vehicle or operating machinery (Mucinex FAST-MAX NIGHT TIME Cold & Flu 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 fever, rash, or headache that lasts. These could be a sign of a serious condition. (Mucinex FAST-MAX DAY TIME Severe Cold only)
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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
- Inactive ingredients
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - Kit Carton
MAXIMUM STRENGTH*
DAY TIME
NIGHT TIMEMAXIMUM STRENGTH*
NDC 63824-551-30
Mucinex®
FAST-MAX®
DAY
TIMESevere Cold
Acetaminophen • Pain Reliever/Fever Reducer
Dextromethorphan HBr • Cough Suppressant
Guaifenesin • Expectorant
Phenylephrine HCl • Nasal DecongestantNEW!
- ✓
-
Relieves Aches,
Fever & Sore Throat - ✓
- Controls Cough
- ✓
-
Relieves Nasal &
Chest Congestion - ✓
- Thins & Loosens Mucus
AGES 12+
20 CAPLETS
NIGHT
TIMECold & Flu
Acetaminophen • Pain Reliever/Fever Reducer
Diphenhydramine HCl• Antihistamine
Phenylephrine HCl • Nasal Decongestant- ✓
-
Relieves Aches,
Fever & Sore Throat - ✓
- Relieves Nasal Congestion
- ✓
-
Relieves Runny Nose
& Sneezing
10 CAPLETS
-
INGREDIENTS AND APPEARANCE
MUCINEX FAST-MAX DAY TIME SEVERE COLD AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH
acetaminophen, dextromethorphan hydrobromide, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-551 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-551-30 1 in 1 CARTON 05/01/2013 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 2 BLISTER PACK 20 Part 2 1 BLISTER PACK 10 Part 1 of 2 MUCINEX FAST-MAX DAY TIME SEVERE COLD MAXIMUM STRENGTH
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, coatedProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 mg Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 5 mg Inactive Ingredients Ingredient Name Strength croscarmellose sodium (UNII: M28OL1HH48) CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) FD&C Red No. 40 (UNII: WZB9127XOA) aluminum oxide (UNII: LMI26O6933) FD&C Yellow No. 6 (UNII: H77VEI93A8) magnesium stearate (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) polyethylene glycol 3350 (UNII: G2M7P15E5P) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) talc (UNII: 7SEV7J4R1U) titanium dioxide (UNII: 15FIX9V2JP) Product Characteristics Color RED Score no score Shape OVAL Size 20mm Flavor Imprint Code VVV;MSC Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 05/01/2013 Part 2 of 2 MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet, coatedProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 325 mg Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride 25 mg Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 5 mg Inactive Ingredients Ingredient Name Strength starch, corn (UNII: O8232NY3SJ) croscarmellose sodium (UNII: M28OL1HH48) CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) FD&C Blue No. 1 (UNII: H3R47K3TBD) aluminum oxide (UNII: LMI26O6933) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) magnesium stearate (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) polydextrose (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) silicon dioxide (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) titanium dioxide (UNII: 15FIX9V2JP) triacetin (UNII: XHX3C3X673) Product Characteristics Color BLUE Score no score Shape OVAL Size 20mm Flavor Imprint Code 44;544 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 05/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 05/01/2013 Labeler - RB Health (US) LLC (081049410)