Medique at Home Cold Relief

Manufacturer
Unifirst First Aid Corporation
Effective date
2022-03-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:48:47

Label at a glance#

ProductMedique at Home Cold Relief
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN
Label structure17 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)

Acetaminophen 325 mg

Dextromethorphan Hydrobromide 15 mg

Guaifenesin 200 mg

Phenylephrine Hydrochloride 5 mg .

OTC - PURPOSE SECTION

Purpose

Pain reliever/ fever reducer

Cough suppressant

Expectorant

Nasal decongestant

INDICATIONS & USAGE SECTION

Uses

■ for the temporary relief of the following cold/flu symptoms:

■ minor aches and pains ■ headache ■ sore throat ■ nasal congestion ■ cough

■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

■ temporarily reduces fever

WARNINGS SECTION

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg acetaminophen) in 24 hours. 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:

■ 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.

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 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.

■ if you have ever had an allergic reaction to this product or any of its ingredients

■ for more than 10 days unless directed by a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

■ liver disease

■ heart disease

■ high blood pressure

■ thyroid disease

■ diabetes

■ trouble urinating due to an enlarged prostate gland

■ persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema

■ cough that occurs with too much phlegm (mucus)

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 dose

OTC - STOP USE SECTION

Stop use and ask a doctor if

■ nervousness, dizziness, or sleeplessness occur

■ pain, nasal congestion or cough gets worse or lasts for more than 7 days

■ fever gets worse or lasts for 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.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick 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 (see overdose warning)

Adults and children12 years and older

■ take 2 tablets every 6-8 hours

■ swallow whole; do not crush, chew or dissolve

■ do not take more than 8 tablets in 24 hours

Children under 12 years

ask a doctor

OTHER SAFETY INFORMATION

Other information

■ store at room temperature 68º-77ºF (20º-25ºC)

■ keep this product protected from extremes of moisture, heat and light

■ Tamper Evident child resistant packets

■ do not use any opened or torn packets

INACTIVE INGREDIENT SECTION

Inactive ingredients

maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, starch, stearic acid

OTC - QUESTIONS SECTION

Questions or comments? 1-800-634-7680

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medique® @ Home

Multi-Symptom Cold Relief

Acetaminophen 325 mg • Pain Reliever/ Fever Reducer

Dextromethorphan Hydrobromide 15 mg • Cough Suppressant

Guaifenesin 200 mg • Expectorant

Phenylephrine Hydrochloride 5 mg • Nasal Decongestant

Pull to Open

Child-Resistant Packets

*not actual size

50 Packets

(2 Tablets Per Packet)

MDQ ColdMDQ Cold

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1367204acetaminophen 325 MG / dextromethorphan HBr 15 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN3
1367204acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD3
1367204APAP 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY3

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
47682-725-332023-07-28C16284748780-10191ceaa-688a-198a-e063-dbdaa90aec3eMedique @ Home Cold Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47682-725-33Medique at Home Cold Relief2 in 1 PACKETTABLET23
47682-725-33Medique at Home Cold Relief50 in 1 BOXTABLET503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47682-725MEDIQUE AT HOME COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]3Legacy NDC, 2 package rows20220318_b5937b99-380b-52e7-e053-2995a90a2077.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47682-72547682-725-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
da6d7070-a2e2-082d-e053-2a95a90a275eb5937b99-380b-52e7-e053-2995a90a20772022-03-17WarningsExact identifier
spl id: da6d7070-a2e2-082d-e053-2a95a90a275e
spl set id: b5937b99-380b-52e7-e053-2995a90a2077

Reported adverse events (FAERS/openFDA)#

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