Primary Health - Fast Maximum Cold, Flu and Sore Throat Relief Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 PINEAPPLE CHERRY GLYCERIN PROPYLENE GLYCOL PROPYL GALLATE WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE XANTHAN GUM Blue to Bluish Green
Drug Facts
Composition & Profile
Identifiers & Packaging
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (180 mL Bottle) NDC 58602-504-18 PrimaryHealth COMPARE TO Mucinex ® FAST- MAX ® Cold, Flu& Sore Throat Active Ingredients* MAXIMUM STRENGTH** Fast Maximum COLD, FLU & SORE THROAT RELIEF Each dose 20 mL (4 tsp) of oral solution contains: 650 mg - Acetaminophen USP (Pain Reliever/Fever Reducer) 20 mg - Dextromethorphan HBr USP (Cough Suppressant) 400 mg - Guaifenesin USP (Expectorant) 10 mg - Phenylephrine HCl USP (Nasal Decongestant) Relieves Headache & Fever Controls Cough Relieves Nasal & Chest Congestion Thins & Loosens Mucus For Ages 12+ 6 FL OZ (180 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (180 mL Bottle)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (180 mL Bottle) NDC 58602-504-18 PrimaryHealth COMPARE TO Mucinex ® FAST- MAX ® Cold, Flu& Sore Throat Active Ingredients* MAXIMUM STRENGTH** Fast Maximum COLD, FLU & SORE THROAT RELIEF Each dose 20 mL (4 tsp) of oral solution contains: 650 mg - Acetaminophen USP (Pain Reliever/Fever Reducer) 20 mg - Dextromethorphan HBr USP (Cough Suppressant) 400 mg - Guaifenesin USP (Expectorant) 10 mg - Phenylephrine HCl USP (Nasal Decongestant) Relieves Headache & Fever Controls Cough Relieves Nasal & Chest Congestion Thins & Loosens Mucus For Ages 12+ 6 FL OZ (180 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (180 mL Bottle)
Overview
Uses temporarily relieves these common cold and flu symptoms: cough nasal congestion sinus congestion and pressure minor aches and pains sore throat headache temporarily reduces fever temporarily promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Indications & Usage
Uses temporarily relieves these common cold and flu symptoms: cough nasal congestion sinus congestion and pressure minor aches and pains sore throat headache temporarily reduces fever temporarily promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Dosage & Administration
Directions do not take more than directed (see Overdose warning) measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = milliliter; tsp = teaspoon adults and children 12 years of age and older: 20 mL (4 tsp) orally every 4 hours, not to exceed 6 doses in 24 hours children under 12 years of age: do not use unless directed by 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 daily 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.
Purpose
Purposes Pain reliever/fever reducer Cough suppressant Expectorant 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. for children under 12 years of age 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 Avoid foods or beverages that contain caffeine
When Using
When using this product do not use more than directed
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 fever, 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. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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.
Storage & Handling
Other information Each 20 mL contains: sodium 12 mg Store at 20-25°C (68-77°F) tamper evident: do not use if printed seal under cap is torn or missing do not refrigerate dosing cup provided
Questions
Questions or Comments 1-855-274-4122 You may also report side effects to this phone number. *This product is not manufactured or distributed by Reckitt Benckiser, distributor of Mucinex® FAST-MAX® Cold, Flu &Sore Throat **Per 4-hour dose Distributed by: Aurohealth LLC. 2572 Brunswick Pike, Lawrenceville, NJ 08648
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