SEVERE SINUS CONGESTION AND PAIN- acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, coated
Strategic Sourcing Services 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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Active ingredients (in each caplet) | Purpose |
Acetaminophen 325 mg | Pain reliever/fever reducer |
Guaifenesin 200 mg | Expectorant |
Phenylephrine HCl 5 mg | Nasal decongestant |
Uses
- temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
- sinus congestion and pressure
- headache
- nasal congestion
- minor aches and pains
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily reduces fever
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.
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.
Directions
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 |
|
Other information
- store between 20-25ºC (68-77ºF) in a dry place
- retain carton for complete product information
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
PRINCIPAL DISPLAY PANEL
NDC 62011-0240-1
Health Mart®
Compare to Tylenol® Sinus Severe active ingredients†
Sinus Severe
Acetaminophen, Phenylephrine HCl, Guaifenesin
Pain Reliever/Fever Reducer, Nasal Decongestant, Expectorant
Cool Taste • Daytime, Non-Drowsy • For Adults
For Relief Of:
Sinus Headache & Sinus Pressure
Nasal Congestion
Mucus + Chest Congestion
ACTUAL SIZE
24 CAPLETS