Dextromethorphan Hydrobromide, Guaifenesin - Reckitt Benckiser LLC

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-10-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-10-27 02:03:44

Label at a glance#

ProductMucinex Fast-Max Kickstart Severe Congestion and Cough and Mucinex Fast-Max Nighttime Cold and Flu
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, ACETAMINOPHEN, TRIPROLIDINE HYDROCHLORIDE
Label structure13 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
(in each 20 mL)

Kickstart Severe Congestion & Cough
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg

Nighttime Cold & Flu
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Triprolidine HCl 2.5 mg

OTC - PURPOSE SECTION

Purposes
Kickstart Severe Congestion & Cough

Dextromethorphan HBr 20 mg » Cough Suppressant
Guaifenesin 400 mg» Expectorant

Nighttime Cold & Flu
Acetaminophen 650 mg» Pain reliever/fever reducer
Dextromethorphan 20 mg» Cough suppressant
Triprolidine HCl 2.5 mg» Antihistamine

INDICATIONS & USAGE SECTION

Uses


Kickstart Severe Congestion & Cough
■ 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

Nighttime 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 SECTION

Warnings

Nighttime 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

Nighttime Cold & Flu
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.

Nighttime Cold & Flu
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. (Nighttime 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 (N ighttime Cold & Flu only)

■ glaucoma (Nighttime Cold & Flu only)
■ trouble urinating due to an enlarged prostate gland (Nighttime Cold & Flu only)
■ a breathing problem such as emphysema or chronic bronchitis (Nighttime 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 (Nighttime Cold & Flu only)
■ 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 (Nighttime Cold & Flu only)
■ marked drowsiness may occur (Nighttime Cold & Flu only)
■ alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime Cold & Flu only)
■ avoid alcoholic drinks (Nighttime Cold & Flu only)
■ use caution when driving a motor vehicle or operating machinery (Nighttime Cold & Flu only)

Stop use and ask a doctor if
Kickstart Severe Congestion & Cough

■ 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.

Nighttime Cold & Flu
■
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 symtoms occur
■ cough come back, or occurs with fever, rash,
or headache that lasts. These could be signs of
a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

SPL UNCLASSIFIED SECTION

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Posion 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. (Nighttime Cold & Flu only)

In case of overdose, get medical help or contact a Posion Control Center right away. (Kickstart Severe Congestion & Cough only)

DOSAGE & ADMINISTRATION SECTION

Directions
Kickstart Severe Congestion & Cough

■ 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

Nighttime 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 SAFETY INFORMATION

Other information

Kickstart Severe Congestion & Cough
■ each 20 mL contains: sodium 9 mg
■ store at 20-25°C (68-77°F)
■ do not refrigerate


Nighttime Cold & Flu
■ each 20 mL contains: sodium 16 mg
■ store at 20-25°C (68-77°F)
■ do not refrigerate

INACTIVE INGREDIENT SECTION

Inactive ingredients

Kickstart Severe Congestion & Cough
ammonium, glycyrrhizate, anhydrous citric acid, D&C yellow
no. 10, edetate disodium, FD&C blue no. 1, flavor,
glycerin (soy), propylene glycol, purified water,
sodium benzoate, sorbitol, sucralose, trisodium
citrate dihydrate*, xanthan gum
*may contain this ingredient

Nighttime Cold & Flu

ammonium glycyrrhizate, anhydrous citric acid, edetate
disodium, FD&C blue no. 1, FD&C red no.
40, flavor, glycerin (soy), propylene glycol,
purified water, sodium benzoate, sorbitol,
sucralose, xanthan gum

OTC - QUESTIONS SECTION

Questions?
1-866-MUCINEX (1-866-682-4639)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton labelcarton label

back labelback label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130363824999340GTIN-13: 0363824999340
EAN-13: 0363824999340
GTIN-12: 363824999340
UPC-A: 363824999340
GTIN storage (14 digits): 00363824999340
72854-160 label 1.jpg

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Package NDC, Billing unit, Product NDC table
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72854-159-66ML - Milliliter72854-159bfa2fea2-c87c-4631-b787-c9d2e02a367312024-08-12

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Product NDCPackage NDC
72854-16072854-160-26
72854-15972854-159-66
72854-14372854-143-66

Ingredients#

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Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-05-18full-release2026-06-01 01:57:52

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Brand, Generic, Manufacturer table
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spl set id: 34fd2458-9acd-cdf7-e063-6394a90a3d0a

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