FDA Label for Maximum Strength Max Cold And Sinus
View Indications, Usage & Precautions
Maximum Strength Max Cold And Sinus Product Label
The following document was submitted to the FDA by the labeler of this product Aptapharma Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Drug Facts
Active ingredients
(in each 20 mL)
Acetaminophen 650 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
Otc - Purpose
Purpose
Acetaminophen Pain reliever/Fever reducer
Guaifenesin Expectorant
Phenylephrine HCl Nasal decongestant
Indications & Usage
Uses
temporarily relieves these common cold and flu symptoms:
• nasal congestion
• sinus congestion and pressure
• minor aches and pains
• sore throat
• headache
• fever
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Warnings
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 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.
• 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.
• for children under 12 years of age
Ask a doctor before use if you have
• liver disease
• heart disease
• thyroid disease
• high blood pressure
• diabetes
• trouble urinating due to an enlarged prostate gland
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma 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
• redness or swelling is present
• symptoms do not get better within 7 days or are accompanied by a fever
• fever gets worse or lasts more than 3 days
• new symptoms occur
• cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a
serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a health professional before use.
Otc - 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 right
away.
Overdosage
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. Quick medical attention is critical for adults as well as for children even if
you do not notice any signs or symptoms.
Dosage & Administration
Directions
• take only as recommended (see Overdose warning)
• use dosage cup
• mL =milliliter
• do not take more than 6 doses in any 24-hour period
| Adults & children 12 years and older | 20 mL every 4 hours |
| Children under 12 years of age | Do not use |
Other Safety Information
Other information
• each 20 mL contains: sodium 10 mg
• dosage cup provided
• store between IS-30°C (59-86°F)
• do not refrigerate
Inactive Ingredient
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, sorbitol, sucralose, Xanthan gum
Otc - Questions
Questions? Call weekdays from 9:30AM to 4:30 PM EST 1-877-798-5944
Maximum Strength Max Cold & Sinus
AP SAFE NDC 76281-515-25
Compare to Mucinex® FAST-MAX™ Cold & Sinus
Active ingredients*
Maximum Strength
MAX COLD & SINUS
Acetaminophen /
Pain reliever/Fever Reducer
Guaifenesin /Expectorant
Phenylephrine HCl / Nasal decongestant
Cold & Sinus
Relief of:
• Fever & Bodyaches
• Thins & Loosens Mucus
• Nasal & Chest Congestion
Adults- For Ages 12 and over
6 FL OZ ( 177 mL)
DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
Failure to follow these warnings could result in serious consequences.
Manufactured by:
AptaPharma Inc.,
1533 Union Ave.
Pennsauken, NJ 08110
* This product is not manufactured or distributed by Reckitt Benckiser Inc., distributor of Mucinex® FAST-MAX™ Cold &
Sinus.
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* Please review the disclaimer below.