AUROMUCUS - FAST MAXIMUM COLD AND SINUS - acetaminophen, guaifenesin and phenylephrine hydrochloride solution
Aurohealth LLC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Drug Facts
Active ingredients (in each 20 mL (4 tsp) dose)
Acetaminophen, USP 650 mg
Guaifenesin, USP 400 mg
Phenylephrine HCl, USP 10 mg
Purposes
Pain reliever/fever reducer
Expectorant
Nasal decongestant
Uses
- temporarily relieves these common cold and flu symptoms:
- minor aches and pains
- sore throat
- headache
- nasal congestion
- sinus congestion and pressure
- temporarily reduces fever
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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.
Do not use
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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
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 use more than directed
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 persistent headache. 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:
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.
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 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
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
Inactive ingredients
anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
Questions or Comments
1-855-274-4122
You may also report side effects to this phone number.
Distributed by:
Aurohealth LLC.
2572 Brunswick Pike,
Lawrenceville, NJ 08648
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (180 mL Bottle)
AUROHEALTH
NDC 58602-111-18
Compare to the active ingredients in
Mucinex® FAST-MAXTM
Cold & Sinus*
MAXIMUM STRENGTH**
AuroMucus
Fast Maximum
Cold & Sinus
Each dose 20 mL (4 tsp) of oral solution contains:
650 mg - Acetaminophen USP (Pain Reliever/Fever Reducer)
400 mg - Guaifenesin USP (Expectorant)
10 mg - Phenylephrine HCl USP (Nasal Decongestant)
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Relieves Headache & Fever
-
Relieves Nasal & Chest Congestion
-
Thins & Loosens Mucus
For Ages 12+ 6 FL OZ (180 mL)