MEDIQUE AT HOME DECOREL FORTE- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet, film coated

Medique at Home Decorel Forte by

Drug Labeling and Warnings

Medique at Home Decorel Forte by is a Otc medication manufactured, distributed, or labeled by Unifirst First Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each caplet)

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

PURPOSE

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

INDICATIONS & USAGE

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

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.

DO NOT USE

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.

ASK DOCTOR

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

ASK DOCTOR/PHARMACIST

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

WHEN USING

When using this product do not exceed recommended dosage.

ASK DOCTOR

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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

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

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

QUESTIONS

Questions or comments? 1-800-634-7680

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)

INGREDIENTS AND APPEARANCE

MEDIQUE AT HOME DECOREL FORTE 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-735
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 2S7830E561)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TALC (UNII: 7SEV7J4R1U)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	orange	Score	no score
Shape	CAPSULE (Caplet)	Size	17mm
Flavor		Imprint Code	44;546
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-735-33	50 in 1 BOX	09/26/2022
1	NDC: 47682-735-99	2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-735-99	2 in 1 PACKET; Type 0: Not a Combination Product	09/26/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	09/26/2022

Labeler - Unifirst First Aid Corporation (832947092)