Medique Cold & Cough

Medique Cold & Cough
SPL v4
SPL
SPL Set ID e8059137-efba-398c-e053-2a95a90a21f2
Route
ORAL
Published
Effective Date 2022-09-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Acetaminophen (325 mg) Phenylephrine (5 mg)
Inactive Ingredients
Starch, Corn Crospovidone Hypromellose, Unspecified Magnesium Stearate Stearic Acid Titanium Dioxide Polyethylene Glycol, Unspecified Croscarmellose Sodium Microcrystalline Cellulose Povidone Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: AZ;324 Shape: capsule Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-09-26

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)