Unishield Cough & Cold

Unishield Cough & Cold
SPL v2
SPL
SPL Set ID e6ff40aa-f5f9-a5bd-e053-2995a90adabd
Route
ORAL
Published
Effective Date 2022-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

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

Unishield

Cough & Cold

Multi-Symptom

80 Caplets / 2 Caplets Per Packet

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

Phenylephrine HCl 5 mg

Pull To Open

This Package is for Households Without Young Children.

• Pain reliever/fever reducer

• Quiets coughs

• Losens phlem and thins bronchial secretions

• Relieves sinus congestion

Relieves coughs, minor aches, headache, congestions & fever

Tamper Evident Unit Dose Packets

Section 53413-1

Questions or comments? 800-480-5855

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)

Unishield

Cough & Cold

Multi-Symptom

80 Caplets / 2 Caplets Per Packet

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

Phenylephrine HCl 5 mg

Pull To Open

This Package is for Households Without Young Children.

• Pain reliever/fever reducer

• Quiets coughs

• Losens phlem and thins bronchial secretions

• Relieves sinus congestion

Relieves coughs, minor aches, headache, congestions & fever

Tamper Evident Unit Dose Packets

Section 53413-1 (53413-1)

Questions or comments? 800-480-5855

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

All Sections (JSON)