Maximum Strength Cold Tabs

Maximum Strength Cold Tabs
SPL v1
SPL
SPL Set ID e7d4fe9a-eb09-4266-90c9-290f61ce6ad0
Route
ORAL
Published
Effective Date 2024-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 44;546 Shape: capsule Color: orange Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-26

Description

Drug Facts


Medication Information

Description

Drug Facts

Use

Temporarily relieves these symptoms due to the common cold:

  • headache
  • fever
  • 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
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 (1-800-222-1222) 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 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 use.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Section 53414-9

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

Section 55105-1
Active ingredient (In Each Caplet) Purpose
Acetaminophen 325 mg pain reliever/fever reducer
Dextromethorphan HBr 10 mg cough suppressant
Guaifenesin 100mg expectorant
Phenylephrine HCl 5mg nasal decongestant
Directions
  • do not take more than directed
  • adults and children 12 years and over:
    • 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
  • with any other product 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.
Questions?

1-866-651-3660 Monday-Friday 8am-5pm EST

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
Other Information
  • store at 25°C (77°F); excursions permitted between15°-30°C (59°-86°F)
  • avoid excessive heat and humidity
  • tamper-evident sealed packets
  • do not use if packet opened or torn
Inactive Ingredient

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

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.

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
Principal Display Panel 80 Caplet Packet Box

This product is not manufactured or distributed by McNeil-PPC, Inc.

Owner of the registered trademark Tylenol®.

Product #1342

Maximum Strength

Cold Tabs

Pain Reliever/Fever Reducer

Decongestant/Expectorant

Cough Suppressant

Active ingredient:

Acetaminophen,

Dextromethorphan,

Guaifenesin, Phenylephrine

  • Helps reduce congestion, sinus pain and pressure,

    cough, fever, minor aches and pain

These quality comfort tablets are formulated and packaged for use in the

workplace and meet ANSI Z308.1-2021 standards. They are sealed in tamper-evi-

dent packets for safety and convenience.

80 Caplets • 2 Caplets Per Packet


Structured Label Content

Use

Temporarily relieves these symptoms due to the common cold:

  • headache
  • fever
  • 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
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 (1-800-222-1222) 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 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 use.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredient (In Each Caplet) Purpose
Acetaminophen 325 mg pain reliever/fever reducer
Dextromethorphan HBr 10 mg cough suppressant
Guaifenesin 100mg expectorant
Phenylephrine HCl 5mg nasal decongestant
Directions
  • do not take more than directed
  • adults and children 12 years and over:
    • 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 product 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.
Questions?

1-866-651-3660 Monday-Friday 8am-5pm EST

Liver Warning (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
Other Information
  • store at 25°C (77°F); excursions permitted between15°-30°C (59°-86°F)
  • avoid excessive heat and humidity
  • tamper-evident sealed packets
  • do not use if packet opened or torn
Inactive Ingredient (Inactive ingredient)

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

Sore Throat Warning (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.

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
Principal Display Panel 80 Caplet Packet Box (PRINCIPAL DISPLAY PANEL - 80 Caplet Packet Box)

This product is not manufactured or distributed by McNeil-PPC, Inc.

Owner of the registered trademark Tylenol®.

Product #1342

Maximum Strength

Cold Tabs

Pain Reliever/Fever Reducer

Decongestant/Expectorant

Cough Suppressant

Active ingredient:

Acetaminophen,

Dextromethorphan,

Guaifenesin, Phenylephrine

  • Helps reduce congestion, sinus pain and pressure,

    cough, fever, minor aches and pain

These quality comfort tablets are formulated and packaged for use in the

workplace and meet ANSI Z308.1-2021 standards. They are sealed in tamper-evi-

dent packets for safety and convenience.

80 Caplets • 2 Caplets Per Packet


Advanced Ingredient Data


Raw Label Data

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