Thompson Cough & Cold

Thompson Cough & Cold
SPL v3
SPL
SPL Set ID e77725b1-15da-35bd-e053-2a95a90ad6ba
Route
ORAL
Published
Effective Date 2022-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (100 mg) Phenylephrine (5 mg) Acetaminophen (325 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Stearic Acid Fd&c Yellow No. 6 Polyethylene Glycol, Unspecified Magnesium Stearate Microcrystalline Cellulose Talc Maltodextrin Polyvinyl Alcohol, Unspecified Povidone Silicon Dioxide Sodium Starch Glycolate Type A Potato Titanium Dioxide Starch, Corn Crospovidone

Identifiers & Packaging

Pill Appearance
Imprint: 44;546 Shape: capsule Color: orange 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 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 a severe skin reactions. Symptoms may include:

■ blisters

■ rash

■ skin reddening

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.

Indications and Usage

Uses

Temporarily relieves these symptoms due to the common cold:

■ headache

■ nasal congestion

■ cough

■ minor aches and pains

■ sore throat

■ sinus congestion and pressure

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

Temporarily reduces fever.

Dosage and Administration

Directions

do not take more than directed

Adults and children: (12 years and over)

■ take 2 caplets every 4 hours

■ not to take more than 10 caplets in 24 hours

Children under 12 years: ask a doctor

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Prompt 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, cough or nasal congestion 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

■ difficulty in urination due to enlargement of the prostate gland

■ cough that occurs with too much phlegm (mucus)

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

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

■ 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.

Section 51727-6

Inactive ingredients

corn starch, crospovidone, FD&C yellow # 6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Section 51945-4

Thompson

Cough & Cold

Multi-Symptom Relief

Safety Works | Business Thrives™

This Package is for Households without Young Children.

Pull to Open

Aches, Fever

Acetaminophen 325 mg

Coughs

Dextromethorphan HBr 10 mg

Chest Congestion

Guaifenesin 100 mg

Nasal Congestion

Phenylephrine HCl 5 mg

80 Caplets

Tamper Evident Sealed Packets

Section 53413-1

Questions or comments? 877.506.4291

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Section 55106-9

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

Phenylephrine HCl 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 symptoms due to the common cold:

■ headache

■ nasal congestion

■ cough

■ minor aches and pains

■ sore throat

■ sinus congestion and pressure

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

Temporarily reduces fever.

Dosage and Administration (34068-7)

Directions

do not take more than directed

Adults and children: (12 years and over)

■ take 2 caplets every 4 hours

■ not to take more than 10 caplets in 24 hours

Children under 12 years: ask a doctor

Warnings and Precautions (34071-1)

Warnings

Liver warning: This product contains acetaminophen. 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 a severe skin reactions. Symptoms may include:

■ blisters

■ rash

■ skin reddening

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.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Prompt 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, cough or nasal congestion 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

■ difficulty in urination due to enlargement of the prostate gland

■ cough that occurs with too much phlegm (mucus)

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

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

■ 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.

Section 51727-6 (51727-6)

Inactive ingredients

corn starch, crospovidone, FD&C yellow # 6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Section 51945-4 (51945-4)

Thompson

Cough & Cold

Multi-Symptom Relief

Safety Works | Business Thrives™

This Package is for Households without Young Children.

Pull to Open

Aches, Fever

Acetaminophen 325 mg

Coughs

Dextromethorphan HBr 10 mg

Chest Congestion

Guaifenesin 100 mg

Nasal Congestion

Phenylephrine HCl 5 mg

80 Caplets

Tamper Evident Sealed Packets

Section 53413-1 (53413-1)

Questions or comments? 877.506.4291

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

Expectorant

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

Phenylephrine HCl 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

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