Mucinex Junior

Manufacturer
RB Health (US)LLC
Effective date
2021-12-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:20:42

Label at a glance#

ProductMucinex Junior Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves these common cold and flu symptoms: cough nasal congestion headache sore throat minor aches and pains 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 productive

Dosage and administration

this product does not contain directions or complete warnings for adult use do not give more than directed (see Overdose warning ) dose as follows or as directed by a doctor children 6 to under 12 years of age: give 2 caplets every 4 hours while symptoms last; do not give more than 5 doses in any 24-hour period children under 6 years of age: do not use

Storage and handling

Store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each caplet)Purposes
Acetaminophen 162.5 mgPain reliever/fever reducer
Dextromethorphan HBr 5 mgCough suppressant
Guaifenesin 100 mgExpectorant
Phenylephrine HCl 2.5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these common cold and flu symptoms:
    • cough
    • nasal congestion
    • headache
    • sore throat
    • minor aches and pains
    • 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 productive

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if your child takes:

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

Allergy alert

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product do not use more than directed (see Overdose warning)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 5 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

SPL UNCLASSIFIED SECTION

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 even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
    (see Overdose warning)
  • dose as follows or as directed by a doctor
  • children 6 to under 12 years of age: give 2 caplets every 4 hours while symptoms last; do not give more than 5 doses in any 24-hour period
  • children under 6 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

  • Store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, crospovidone, FD&C blue no. 1 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

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 - 20 Caplet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pediatrician Recommended†
NDC 63824-670-20

NEW

Mucinex®
Junior
COLD & FLU

Acetaminophen 162.5 mg – Pain Reliever/Fever Reducer
Dextromethorphan HBr 5 mg – Cough Suppressant
Guaifenesin 100 mg – Expectorant
Phenylephrine HCl 2.5 mg – Nasal Decongestant

Ages
6+
yrs

SORE THROAT
FEVER

CHEST CONGESTION
COUGH

NASAL CONGESTION
SINUS CONGESTION
SINUS PRESSURE

HEADACHE
BODY PAIN

ALL IN
ONE*

Junior Caplet±
Actual Size

20 CAPLETS
DO NOT CHEW

PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Carton
PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Carton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-670-20EA - Each63824-670ef8394a4-d6d1-4c6b-9e4d-c4774ea3204812020-05-08

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63824-67063824-670-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dfc384cc-8250-4c0b-946a-75c0f9fa0e749589678c-cd65-4c38-a838-ea2e3ba2cf682021-12-23WarningsExact identifier
spl id: dfc384cc-8250-4c0b-946a-75c0f9fa0e74
spl set id: 9589678c-cd65-4c38-a838-ea2e3ba2cf68

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.