Physicians Care Non-drowsy Cold & Cough

Physicians Care Non-drowsy Cold & Cough
SPL v3
SPL
SPL Set ID 186ec543-1f23-75d6-e063-6294a90a46b9
Route
ORAL
Published
Effective Date 2023-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 44;546 Shape: capsule Color: orange Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-19

Description

Drug Facts

Purpose

Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Description

Drug Facts

Uses

Uses

Temporarily relieves these cold symptoms

  • cough
  • sore throat
  • minor aches and pains
  • headache
  • nasal congestion
  • sinus congestion and pressure
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive

Temporarily reduces fever.

Warnings

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 severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

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.

Questions

Questions? 1-800-835-2263

Directions

Directions

  • do not take more than directed

Adults and children: (12 years and older)

Take 2 caplets every 4 hours

Do not to take more than 10 caplets in 24 hours

Children under 12 years: ask a doctor

Do Not Use

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.
Drug Facts

Drug Facts

Active Ingredient

Active ingredient (in each caplet)

Acetaminophen 325 mg

Dextromethorphan Hydrobromide 10 mg

Guaifenesin 100 mg

Phenylephrine Hydrochloride 5 mg

Other 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 Ingredients

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

Physicians Care Cold & Cough

91462

PhysiciansCare®

Non-Drowsy

Cold & Cough

Cold, Cough and Flu Relief

Pull

to Open

COATED CAPLET

Individually packaged for workplace use

Tamper-Evident Packets of 2 Caplets

Do not use if packet is open or torn.

Not Actual Size

100 Caplets (50 Packets, 2 caplets each)

Stop Use and Ask A Doctor If

Stop use and ask a doctor if

  • new symptons occur
  • redness or swelling is present
  • pain, cough or nasal congestion gest worse or lasts for more than 7 days
  • fever gets worse or lasts more than 3 days
  • nervousness, dizziness, or sleeplessness occur
  • cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

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

Keep Out of Reach of Children.

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.

Ask A Doctor Before Use If You Have

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
Ask A Doctor Or Pharmacist Before Use If You Are

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin.
When Using This Product Do Not Exceed Recommended Dosage.

When using this product do not exceed recommended dosage.


Structured Label Content

Uses

Uses

Temporarily relieves these cold symptoms

  • cough
  • sore throat
  • minor aches and pains
  • headache
  • nasal congestion
  • sinus congestion and pressure
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive

Temporarily reduces fever.

Purpose

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Warnings

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 severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

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.

Questions

Questions? 1-800-835-2263

Directions

Directions

  • do not take more than directed

Adults and children: (12 years and older)

Take 2 caplets every 4 hours

Do not to take more than 10 caplets in 24 hours

Children under 12 years: ask a doctor

Do Not Use (Do not use)

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.
Drug Facts

Drug Facts

Active Ingredient

Active ingredient (in each caplet)

Acetaminophen 325 mg

Dextromethorphan Hydrobromide 10 mg

Guaifenesin 100 mg

Phenylephrine Hydrochloride 5 mg

Other Information (Other 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 Ingredients (Inactive ingredients)

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

Physicians Care Cold & Cough

91462

PhysiciansCare®

Non-Drowsy

Cold & Cough

Cold, Cough and Flu Relief

Pull

to Open

COATED CAPLET

Individually packaged for workplace use

Tamper-Evident Packets of 2 Caplets

Do not use if packet is open or torn.

Not Actual Size

100 Caplets (50 Packets, 2 caplets each)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Stop use and ask a doctor if

  • new symptons occur
  • redness or swelling is present
  • pain, cough or nasal congestion gest worse or lasts for more than 7 days
  • fever gets worse or lasts more than 3 days
  • nervousness, dizziness, or sleeplessness occur
  • cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

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

Keep Out of Reach of Children. (Keep out of reach of children.)

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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin.
When Using This Product Do Not Exceed Recommended Dosage. (When using this product do not exceed recommended dosage.)

When using this product do not exceed recommended dosage.


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