Cold and Head Congestion Severe ACETAMINOPHEN GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE TOPCO ASSOCIATES LLC FDA Approved Uses for the temporary relief of the following cold symptoms: minor aches and pains headache sore throat nasal congestion sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever
FunFoxMeds box
Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant
Inactive Ingredients
Inactive ingredients acesulfame potassium colloidal silicon dioxide croscarmellose sodium crospovidone flavor magnesium stearate maltodextrin microcrystalline cellulose polyethylene glycol polyvinyl alcohol povidone pregelatinized starch propylene glycol stearic acid talc titanium dioxide
Strengths
325 mg 200 mg 5 mg
Treats Conditions
Uses For The Temporary Relief Of The Following Cold Symptoms Minor Aches And Pains Headache Sore Throat Nasal Congestion Sinus Congestion And Pressure Helps Loosen Phlegm Mucus And Thin Bronchial Secretions To Make Coughs More Productive Temporarily Reduces Fever
Pill Appearance
Shape: oval Color: white Imprint: AAA;1119

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
362O9ITL9D 495W7451VQ 04JA59TNSJ
Packaging

PRINCIPAL DISPLAY PANEL NDC 36800-575-02 TopCare® Health Compare to Tylenol® Cold + Head Congestion Severe Active Ingredients† Cold + Head Congestion Severe SEVERE Acetaminophen, Phenylephrine, Guafenesin Pain Reliever/Fever Reducer, Nasal Decongestant, Expectorant Relief of: • Headache + Body Aches • Fever + Sore ThroaT • Nasal Congestion • Mucus + Chest Congestion For Adults 24 COOL TASTE CAPLETS actual size image description

Package Descriptions
  • PRINCIPAL DISPLAY PANEL NDC 36800-575-02 TopCare® Health Compare to Tylenol® Cold + Head Congestion Severe Active Ingredients† Cold + Head Congestion Severe SEVERE Acetaminophen, Phenylephrine, Guafenesin Pain Reliever/Fever Reducer, Nasal Decongestant, Expectorant Relief of: • Headache + Body Aches • Fever + Sore ThroaT • Nasal Congestion • Mucus + Chest Congestion For Adults 24 COOL TASTE CAPLETS actual size image description

Overview

Uses for the temporary relief of the following cold symptoms: minor aches and pains headache sore throat nasal congestion sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever

Indications & Usage

Uses for the temporary relief of the following cold symptoms: minor aches and pains headache sore throat nasal congestion sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever

Dosage & Administration

Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years ask a doctor

Warnings & Precautions
Warnings Liver warning This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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, perists 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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) 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 Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts 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. Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Purpose

Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant

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

When Using

When using this product do not exceed recommended dosage

Stop Use & Ask a Doctor

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts 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.

Storage & Handling

Other information store between 20-25ºC (68-77ºF) in a dry place retain carton for complete product information


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