MUCINEX FAST-MAX COLD AND FLU MAXIMUM STRENGTH- acetaminophen, dextromethorphan hydrobromide capsule, liquid filled

Mucinex Fast-Max Cold and Flu by

Drug Labeling and Warnings

Mucinex Fast-Max 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 liquid gel) Purposes
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant

Active ingredients (in each liquid gel)	Purposes
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant

Uses

temporarily relieves these common cold and flu symptoms:

■ 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
■ minor aches and pains
■ sore throat
■ headache
■ temporarily reduces fever

Warnings

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

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.

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 (precription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you are now taking a precription 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 precription 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
• persistant 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

■ pain 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.

If pregnant or breast-feeding, ask a health professional before use.

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 over: take 2 liquid gels every 4 hours
• children under 12 years of age: do not use

Other information

• store at 20-25°C (68-77°F)
• avoid excessive heat

Inactive ingredients

FD&C red no. 40, FD&C yellow
no. 6, gelatin, glycerin, hypromellose, isopropyl alcohol,
lecithin (sunflower), light mineral oil, mannitol, polyethylene
glycol 400, povidone, propylene glycol, purified water,
1,4-sorbitan, sorbitol, titanium dioxide

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 - 16 Capsule Blister Pack Carton

Fast Dissolving Liquid Gels!

NDC: 72854-171

MAXIMUM STRENGTH

MUCINEX®

FAST-MAX ®

COLD & FLU

Acetaminophen – Pain Reliever/Fever Reducer

Dextromethorphan HBr – Cough Suppressant

LIQUID GELS

(Liquid Filled Capsules)

Actual Size

FOR AGES 12 +

INGREDIENTS AND APPEARANCE

MUCINEX FAST-MAX COLD AND FLU  MAXIMUM STRENGTH
acetaminophen, dextromethorphan hydrobromide capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72854-171
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

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
MANNITOL (UNII: 3OWL53L36A)
1,4-SORBITAN (UNII: AV0YTZ4E6J)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	24mm
Flavor		Imprint Code	AR18
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72854-171-16	2 in 1 CARTON	06/01/2025
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 72854-171-08	1 in 1 CARTON	06/01/2025
2		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 72854-171-10	1 in 1 CARTON	06/01/2025
3		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 Drug	M012	06/01/2025

Labeler - RB Health (US) LLC (081049410)