Label: MUCINEX FAST MAX LIQUID COLD AND FLU KICKSTART AND MUCINEX NIGHTSHIFT KICKSTART- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci, triprolidine hci kit
- NDC Code(s): 72854-138-66, 72854-139-26, 72854-140-66
- 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 June 9, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
-
ACTIVE INGREDIENT
KICKSTART SEVERE COLD & FLU:
Acetaminophen 650mg.................................Pain reliever/fever reducer
Dextromethorphan HBr 20 mg.....................................Cough suppressant
Guaifenesin 400 mg........................................................Expectorant
Phenylephrine HCl 10mg........................................Nasal decongestantNIGHT TIME SEVERE COLD & FLU:
Acetaminophen 650mg............................ ....Pain reliever/fever reducer
Dextromethorphan HBr 20 mg....................................Cough suppressant
Phenylephrine HCl 10mg................................... . . . .Nasal decongestant
Triprolidine HCl 2.5 mg................................................Antihistamine -
Uses
KICKSTART SEVERE COLD & FLU:
temporarily relieves these common cold and flu symptoms:
■ cough
■ nasal congestion
■ minor aches and pains
■ sore throat
■ headache■ stuffy nose
■ sinus congestion and pressure
■ temporarily reduces fever
■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial
passageways of bothersome mucus and make coughs more productiveNIGHT TIME SEVERE COLD & FLU:
temporarily relieves these common cold and flu symptoms:
■ cough
■ nasal congestion
■ minor aches and pains
■ sore throat
■ headache■ sinus congestion and pressure
■ runny nose
■ sneezing
■ itching of the nose or throat
■ itchy, watery eyes due to hay fever
■ temporarily reduces fever
■ controls cough to help you get to sleep -
Warnings
KICKSTART SEVERE COLD & FLU:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
you take:
■ more than 6 doses 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.
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.
■ 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.NIGHT TIME SEVERE COLD & FLU:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
you take:
■ more than 4,000 mg 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.
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.
■ 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
■ glaucoma
■ trouble urinating due to an enlarged prostate gland
■ a breathing problem such as emphysema or chronic bronchitis
■ persistent or chronic cough such as occurs with smoking, asthma, 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
■ taking sedatives or tranquilizers
When using this product■ do not use more than directed
■ excitability may occur, especially in children
■ marked drowsiness may occur
■ alcohol, sedatives, and tranquilizers may increase drowsiness
■ avoid alcoholic drinks
■ use caution when driving a motor vehicle or operating machinery
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.
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Directions
KICKSTART SEVERE COLD & FLU
■ do not take more than directed (see
Overdose warning)
■ do not take more than 6 doses in any
24-hour period
■ measure only with dosing cup provided
■ do not use dosing cup with other products
■ dose as follows or as directed by a doctor
■ adults and children 12 years of age and
over: 20 mL in dosing cup provided
every 4 hours
■ children under 12 years of age: do not useNIGHT TIME SEVERE COLD & FLU
■ do not take more than directed (see
Overdose warning)
■ do not take more than 4 doses in any
24-hour period
■ measure only with dosing cup provided
■ do not use dosing cup with other products
■ dose as follows or as directed by a doctor
■ adults and children 12 years of age and
over: 20 mL in dosing cup provided
every 4 hours
■ children under 12 years of age: do not use
- Other Information
-
INACTIVE INGREDIENT
KICKSTART SEVERE COLD & FLU
ammonium glycyrrhizate, anhydrous citric acid, D&C
yellow no. 10, edetate disodium, FD&C blue
no. 1, flavors, glycerin, propylene glycol,
purified water, sodium benzoate, sodium
citrate, sorbitol, sucralose, xanthan gumNIGHT TIME SEVERE COLD & FLU
ammonium glycyrrhizate, anhydrous citric acid, ascorbic
acid, edetate disodium, FD&C blue no. 1,
FD&C red no. 40, flavors, glycerin (soy),
propylene glycol, sodium benzoate, sorbitol,
sucralose, triacetin, triethyl citrate, water,
xanthan gum - QUESTIONS
- KEEP OUT OF REACH OF CHILDREN
-
Purposes
KICKSTART SEVERE COLD & FLU:
Dextromethorphan HBr 20 mg.....................................Cough suppressant
Guaifenesin 400 mg........................................................Expectorant
Phenylephrine HCl 10mg........................................Nasal decongestantNIGHT TIME SEVERE COLD & FLU:
Dextromethorphan HBr 20 mg....................................Cough suppressant
Phenylephrine HCl 10mg................................... . . . .Nasal decongestant
Triprolidine HCl 2.5 mg................................................Antihistamine -
PRINCIPAL DISPLAY PANEL
NDC 72854-139
MUCINEX FAST-MAX Kickstart + Nighttime Cold & Flu Pack
Kickstart Severe Cold & Flu:
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant • Phenylephrine HCl – Nasal DecongestantNighttime Severe Cold & Flu:
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Phenylephrine HCl – Nasal Decongestant • Triprolidine HCl – AntihistamineFOR
AGES 12+
TWO – 6 FL OZ (180 mL) bottlesTOTAL – 12 FL OZ (360 mL)
-
INGREDIENTS AND APPEARANCE
MUCINEX FAST MAX LIQUID COLD AND FLU KICKSTART AND MUCINEX NIGHTSHIFT KICKSTART
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci, triprolidine hci kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72854-139 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72854-139-26 1 in 1 CARTON 05/01/2023 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 180 mL Part 2 1 BOTTLE 180 mL Part 1 of 2 MUCINEX FAST-MAX KICKSTART SEVERE COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solutionProduct Information Item Code (Source) NDC:72854-138 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 20 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 20 mL ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 20 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg in 20 mL Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) PROPYL GALLATE (UNII: 8D4SNN7V92) Product Characteristics Color green Score Shape Size Flavor MENTHOL Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72854-138-66 180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/01/2023 Part 2 of 2 MUCINEX NIGHT TIME SEVERE COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride solutionProduct Information Item Code (Source) NDC:72854-140 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 20 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 20 mL ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 20 mL TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE 2.5 mg in 20 mL Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) ASCORBIC ACID (UNII: PQ6CK8PD0R) EDETATE DISODIUM (UNII: 7FLD91C86K) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SUCRALOSE (UNII: 96K6UQ3ZD4) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color blue Score Shape Size Flavor FRUIT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72854-140-66 180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/01/2023 Labeler - RB Health (US) LLC (081049410)