Active Ingredients (In Each Caplet)
Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Severe Congestion And Pain Tablet, Film Coated
FDA Label NDC 55319-815
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar Services Inc for the product Severe Congestion And Pain (NDC 55319-815). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever
Expectorant
Nasal decongestant
Uses
- temporarily relieves:
- nasal congestion
- headache
- sinus congestion and pressure
- minor aches and pains
- 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
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- with other drugs containing acetaminophen
- more than 4,000 mg of acetaminophen in 24 hours
- 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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
- thyroid disease
- diabetes
- heart disease
- high blood pressure
- difficulty in urination due to enlargement of the 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
- fever gets worse or lasts more than 3 days
- pain, nasal congestion, or cough gets worse or lasts more than 7 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 right away. Prompt 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
- do not take more than 12 caplets in any 24-hour period
- adults and children 12 years and over: take 2 caplets every 4 hours
- children under 12 years: do not use
Other Information
- each caplet contains: sodium 3 mg
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
corn starch, crospovidone, FD&C red #40 aluminum lake, 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
Questions Or Comments?
1-800-426-9391
Principal Display Panel
FAMILY
Wellness™
*COMPARE TO THE ACTIVE INGREDIENTS
IN MAXIMUM STRENGTH MUCINEX®
SINUS-MAX® SEVERE CONGESTION & PAIN
MAXIMUM STRENGTH
SEVERE
CONGESTION & PAIN
Acetaminophen - Pain Reliever
Guaifenesin - Expectorant
Phenylephrine HCl - Nasal Decongestant
Relieves:
• Headache
• Thins & Loosens Mucus
• Relieves Sinus Congestion
8 CAPLETS
ACTUAL SIZE
NDC 55319-815-19
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR
SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed
by RB Health (US) LLC, owner of the registered
trademark Maximum Strength Mucinex®
SINUS-MAX® Severe Congestion & Pain.
50844 ORG062361519
DISTRIBUTED BY:
MIDWOOD BRANDS, LLC
500 VOLVO PKWY
CHESAPEAKE, VA 23320 USA
NOT 100% SATISFIED?
Return within 30 days to the
store of purchase for a refund
(with receipt) or exchange.
Family Wellness 44-615 (Family Wellness 44 615 Sm 1)
* Please review the disclaimer below.
