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#
Contacts and useful links#
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)
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1367204 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 3 |
| 1367204 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 3 |
| 1367204 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 3 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 47682-725-33 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-688a-198a-e063-dbdaa90aec3e | Medique @ Home Cold Relief |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 47682-725-33 | Medique at Home Cold Relief | 2 in 1 PACKET | TABLET | 2 | 3 | |
| 47682-725-33 | Medique at Home Cold Relief | 50 in 1 BOX | TABLET | 50 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 47682-725 | MEDIQUE AT HOME COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION] | 3 | Legacy NDC, 2 package rows | 20220318_b5937b99-380b-52e7-e053-2995a90a2077.zip |
Products#
Every source-derived product name is available through these pages.
- Medique at Home Cold Relief
- Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
- STARCH, CORN
- STEARIC ACID
- CELLULOSE, MICROCRYSTALLINE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- SILICON DIOXIDE
- GUAIFENESIN
- MALTODEXTRIN
- POVIDONE, UNSPECIFIED
- SODIUM STARCH GLYCOLATE TYPE A CORN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- ACETAMINOPHEN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 47682-725 | 47682-725-33 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| da6d7070-a2e2-082d-e053-2a95a90a275e | b5937b99-380b-52e7-e053-2995a90a2077 | 2022-03-17 | Warnings | da6d7070-a2e2-082d-e053-2a95a90a275e b5937b99-380b-52e7-e053-2995a90a2077 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
