Maximum Strength Cold Tabs ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE JHK DBA AMERICAN SAFETY & FIRST AID FDA Approved 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
FunFoxMeds box
Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
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
Inactive Ingredients
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
Strengths
325 mg 10 mg 100 mg 5 mg
Treats Conditions
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
Pill Appearance
Shape: capsule Color: orange Imprint: 44;546

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
362O9ITL9D 9D2RTI9KYH 495W7451VQ 04JA59TNSJ
Packaging

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 Principal Display Panel - 80 Caplet Packet Box

Package Descriptions
  • 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 Principal Display Panel - 80 Caplet Packet Box

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & 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 warning: acetaminophen may cause severe skin reactions. Syhmptoms 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. 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. 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 taking the blood thinning drug warfarin. When using this product do not exceed recommended use. 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. If pregnant or breast-feeding, ask a health professional before use. 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.
Purpose

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

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.

When Using

When using this product do not exceed recommended use.

Stop Use & Ask a Doctor

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.

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 (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.

Storage & Handling

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

Questions

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


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