Medique Cold & Cough
e8059137-efba-398c-e053-2a95a90a21f2
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Medication Information
Warnings and Precautions
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.
Indications and Usage
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.
Dosage and Administration
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.
Description
Drug Facts
Section 42229-5
Drug Facts
Section 50565-1
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.
Section 50566-9
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.
Section 50567-7
When using this product do not exceed recommended dosage.
Section 50568-5
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Section 50569-3
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)
Section 50570-1
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.
Section 51727-6
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
Section 51945-4
Medique®
Cold & Cough Product
Multi-Symptom Relief
Pull to Open
Pain Reliever/Fever Reducer • Acetaminophen 325 mg
Cough Suppressant • Dextromethorphan HBr 10 mg
Nasal Decongestant • Phenylephrine HCl 5 mg
80 Caplets
(40 x 2)
Tamper Evident Unit Dose Packets
Section 53413-1
Questions or comments? 1-800-634-7680
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Section 55106-9
Active ingredients (in each caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine Hydrochloride 5 mg
Section 60561-8
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
Structured Label Content
Indications and Usage (34067-9)
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.
Dosage and Administration (34068-7)
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.
Warnings and Precautions (34071-1)
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.
Section 42229-5 (42229-5)
Drug Facts
Section 50565-1 (50565-1)
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.
Section 50566-9 (50566-9)
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.
Section 50567-7 (50567-7)
When using this product do not exceed recommended dosage.
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Section 50569-3 (50569-3)
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)
Section 50570-1 (50570-1)
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.
Section 51727-6 (51727-6)
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
Section 51945-4 (51945-4)
Medique®
Cold & Cough Product
Multi-Symptom Relief
Pull to Open
Pain Reliever/Fever Reducer • Acetaminophen 325 mg
Cough Suppressant • Dextromethorphan HBr 10 mg
Nasal Decongestant • Phenylephrine HCl 5 mg
80 Caplets
(40 x 2)
Tamper Evident Unit Dose Packets
Section 53413-1 (53413-1)
Questions or comments? 1-800-634-7680
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1 (55105-1)
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Section 55106-9 (55106-9)
Active ingredients (in each caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine Hydrochloride 5 mg
Section 60561-8 (60561-8)
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
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Raw Label Data
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Source: dailymed · Ingested: 2026-02-15T12:06:57.469641 · Updated: 2026-03-14T23:10:05.459246