MUCINEX FAST-MAX DM MAX AND MUCINEX NIGHTSHIFT COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and triprolidine hydrochloride kit

Mucinex Fast-Max DM Max and Mucinex Nightshift Cold and Flu by

Drug Labeling and Warnings

Mucinex Fast-Max DM Max and Mucinex Nightshift Cold and Flu by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 20 mL) MUCINEX FAST-MAX DM MAX	Purposes
Dextromethorphan HBr 20 mg	Cough suppressant
Guaifenesin 400 mg	Expectorant

Active ingredients (in each 20 mL) MUCINEX NIGHTSHIFT COLD & FLU	Purposes
Acetaminophen 650 mg	Pain reliever/fever reducer
Dextromethorphan HBr 20 mg	Cough suppressant
Triprolidine HCl 2.5 mg	Antihistamine

Uses
MUCINEX FAST-MAX DM MAX
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
  - cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  - the intensity of coughing
  - the impulse to cough to help you get to sleep
MUCINEX NIGHTSHIFT COLD & FLU
- temporarily relieves these common cold and flu symptoms:
  - cough
  - minor aches and pains
  - sore throat
  - headache
  - 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
Liver warning (Nightshift Cold & Flu only)

This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4000 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 (Nightshift Cold & Flu only)

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 (Nightshift Cold & Flu only)

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. (Nightshift 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.
Ask a doctor before use if you have
- liver disease (Nightshift Cold & Flu only)
- glaucoma (Nightshift Cold & Flu only)
- trouble urinating due to an enlarged prostate gland (Nightshift Cold & Flu only)
- a breathing problem such as emphysema or chronic bronchitis (Nightshift Cold & Flu only)
- 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 (Nightshift Cold & Flu only)
- taking sedatives or tranquilizers (Nightshift Cold & Flu only)
When using this product
- do not use more than directed
- excitability may occur, especially in children (Nightshift Cold & Flu only)
- marked drowsiness may occur (Nightshift Cold & Flu only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (Nightshift Cold & Flu only)
- avoid alcoholic drinks (Nightshift Cold & Flu only)
- use caution when driving a motor vehicle or operating machinery (Nightshift Cold & Flu only)
Stop use and ask a doctor if
- pain or cough gets worse or lasts more than 7 days (Nightshift Cold & Flu only)
- fever gets worse or lasts more than 3 days (Nightshift Cold & Flu only)
- redness or swelling is present (Nightshift Cold & Flu only)
- new symptoms occur (Nightshift Cold & Flu only)
- cough comes back or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. (Nightshift Cold & Flu only)
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. (Fast-Max DM Max only)
If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Overdose warning (Nightshift Cold & Flu only)

Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
MUCINEX FAST-MAX DM MAX
- 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 use
MUCINEX NIGHTSHIFT 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
- each 20 mL contains: sodium 12 mg (Fast-Max DM Max only) and sodium 16 mg (Nightshift Cold & Flu only)
- store at 20-25°C (68-77°F)
- do not refrigerate
Inactive ingredients (MUCINEX FAST-MAX DM MAX)

anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, glycerin (soy), propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate 1, xanthan gum

1 may contain this ingredient

Inactive ingredients (MUCINEX NIGHTSHIFT 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?

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

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US), Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - Kit Carton

DAY & NIGHT
COUGH & COLD RELIEF

MAXIMUM STRENGTH
NDC: 63824-118-66

Mucinex®
FAST-MAX ®

DM MAX

Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant

Controls Cough
Relieves Chest Congestion
Thins & Loosens Mucus
4 Hour Dosing

Mucinex®
NIGHTSHIFT

COLD & FLU

Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Triprolidine HCl – Antihistamine

NIGHTTIME
RELIEF FOR A BETTER
MORNING

✓COUGH ✓FEVER ✓SORE THROAT
✓RUNNY NOSE ✓SNEEZING

FOR
AGES 12+

TWO – 6 FL OZ (180 mL) bottles
TOTAL – 12 FL OZ (360 mL)

FOR
AGES 12+

INGREDIENTS AND APPEARANCE

MUCINEX FAST-MAX DM MAX AND MUCINEX NIGHTSHIFT COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and triprolidine hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-118

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 63824-118-66	1 in 1 CARTON	06/30/2022

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 BOTTLE	180 mL
Part 2	1 BOTTLE	180 mL

Part 1 of 2

MUCINEX NIGHTSHIFT COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, and triprolidine hydrochloride solution

Product Information
Item Code (Source)	NDC: 63824-503
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg in 20 mL
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	2.5 mg in 20 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TRIACETIN (UNII: XHX3C3X673)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	FRUIT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 63824-503-66	180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	06/15/2019

Part 2 of 2

MUCINEX FAST-MAX DM MAX
dextromethorphan hydrobromide and guaifenesin solution

Product Information
Item Code (Source)	NDC: 63824-019
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg in 20 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYL GALLATE (UNII: 8D4SNN7V92)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 63824-019-66	180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	07/18/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	06/20/2019

Labeler - RB Health (US) LLC (081049410)