Medique Cold Cough Product
- Manufacturer
- Sportpharm LLC | ASCLEMED USA INC. DBA ENOVACHEM
- Effective date
- 2026-02-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:37:55
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 caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine Hydrochloride 5 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
INDICATIONS & USAGE SECTION
Uses
temporarily relieves these common cold/flu symptoms:
■ minor aches and pains
■ headache
■ sore throat
■ nasal congestion
■ cough
■ sinus congestion and pressure
■ 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. Severe liver damage may occur if you take:
■ more than 12 caplets in 24 hours, which is the maximum daily amount
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while using this product
Allergy alert:acetaminophen may cause a severe skin reactions. Symptoms may include:
■ skin reddening
■ blisters
■ rash
If a skin reaction occurs, stop use and seek medical help immediately.
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 drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist.
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 such as occurs with smoking, asthma, or emphysema
■ cough that occurs with too much phlegm (mucus)
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin.
OTC - WHEN USING SECTION
When using this product do not exceed recommended dosage.
OTC - STOP USE SECTION
Stop use and ask a doctor if
■ nervousness, dizziness, or sleeplessness occur
■ pain gets worse or lasts for 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, contact a doctor or Poison Control Center (1-800-222-1222) immediately. Taking more than the recommended dose (overdose) may cause liver damage. 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 Warnings)
Adults and children: (12 years and over)
■ take 2 caplets every 4 hours
■ do not take more than 12 caplets in 24 hours
Children under 12 years:do not use this adult product in children under 12 years of age. This will provide more
than the recommended dose (overdose) and may cause liver damage.
OTHER SAFETY INFORMATION
Other information
■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
■ tamper evident sealed packets
■ do not use any opened or torn packets
INACTIVE INGREDIENT SECTION
Inactive ingredients
colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments?1-800-634-7680
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1094538 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 1 |
| 1094538 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 1 |
| 1094538 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85766-162-36 | Medique Cold Cough Product | 75 in 1 BOX | TABLET, FILM COATED | 75 | 1 | |
| 85766-162-36 | Medique Cold Cough Product | 2 in 1 PACKET | TABLET, FILM COATED | 2 | 1 | |
| 85766-162-80 | Medique Cold Cough Product | 40 in 1 BOX | TABLET, FILM COATED | 40 | 1 | |
| 85766-162-80 | Medique Cold Cough Product | 2 in 1 PACKET | TABLET, FILM COATED | 2 | 1 |
Products#
Every source-derived product name is available through these pages.
- Medique Cold Cough Product
- Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl ,
- STARCH, CORN
- CROSPOVIDONE
- HYPROMELLOSE, UNSPECIFIED
- MAGNESIUM STEARATE
- STEARIC ACID
- TITANIUM DIOXIDE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- CROSCARMELLOSE SODIUM
- MICROCRYSTALLINE CELLULOSE
- POVIDONE
- SILICON DIOXIDE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- ACETAMINOPHEN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85766-162 | 85766-162-80, 85766-162-36 |
| 47682-108 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| Medique Cold Cough Product | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , | Sportpharm LLC | d61df3a4-8ae2-46b1-b322-7f4e04cc1bf9 | 2026-02-09 | Warnings | 85766-162-80 85766-162-36 85766-162 85766016280 85766016236 4a5ea172-8d70-4e54-e063-6394a90a4fd1 d61df3a4-8ae2-46b1-b322-7f4e04cc1bf9 |
| Medique Cold Cough Product | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , | Unifirst First Aid Corporation | e8059137-efba-398c-e053-2a95a90a21f2 | 2025-09-08 | Warnings | 47682-108 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
