Medique at Home Decorel Forte

Manufacturer
Unifirst First Aid Corporation
Effective date
2025-09-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:13:21

Label at a glance#

ProductMedique at Home Decorel Forte
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN
Label structure17 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each caplet)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 100 mg
Phenylephrine HCl 5 mg

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves these symptoms due to the common cold:

  • headache
  • nasal congestion
  • cough
  • minor aches and pains
  • sore throat
  • sinus congestion and pressure
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive

Temporarily reduces fever.

WARNINGS SECTION

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • blisters
  • rash
  • skin reddening

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.

OTC - DO NOT USE SECTION

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 have ever had an allergic reaction to this product or any of its ingredients
  • 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis, or emphysema

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

OTC - WHEN USING SECTION

When using this product do not exceed recommended dosage.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain, cough, or nasal congestion 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than directed

Adults and children: (12 years and over):

  • take 2 caplets every 4 hours
  • not to take more than 10 caplets in 24 hours

Children under 12 years: ask a doctor

OTHER SAFETY INFORMATION

Other information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • TAMPER EVIDENT child resistant packets
  • do not use any opened or torn packets

INACTIVE INGREDIENT SECTION

Inactive ingredients

corn starch, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments? 1-800-634-7680

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medique® @ Home

Decorel Forte

Acetaminophen 325 mg • Pain Reliever/Fever Reducer
Dextromethorphan HBr 10 mg • Cough Suppressant
Guaifenesin 100 mg • Expectorant
Phenylephrine HCl 5 mg • Nasal Decongestant

Pull to Open

Child-Resistant Packets

*not actual size

50 Packets

(2 Caplets Per Packet)

MDQ435BMDQ435B

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1098435acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 100 MG / phenylephrine HCl 5 MG Oral TabletPSN5
1098435acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD5
1098435APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 100 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47682-735-33Medique at Home Decorel Forte50 in 1 BOXTABLET, FILM COATED505
47682-735-99Medique at Home Decorel Forte2 in 1 PACKETTABLET, FILM COATED25

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
47682-73547682-735-99, 47682-735-33

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

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
Medique at Home Decorel ForteACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporatione648f017-9e30-df6c-e053-2995a90adcd02025-09-09WarningsExact identifier
ndc (package): 47682-735-33
ndc (package): 47682-735-99
ndc (product): 47682-735
ndc11 (package): 47682073533
ndc11 (package): 47682073599
spl id: 3e5d5a8f-273f-dd38-e063-6394a90ab6af
spl set id: e648f017-9e30-df6c-e053-2995a90adcd0