FDA Label for Multi-symptom Sinus Severe Congestion
View Indications, Usage & Precautions
- OTC - PURPOSE
- USES
- LIVER WARNING
- ALLERGY ALERT
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - ASK DOCTOR/PHARMACIST
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 2 TABLET PACKET CARTON
Multi-symptom Sinus Severe Congestion Product Label
The following document was submitted to the FDA by the labeler of this product Lil' Drug Store Products, 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 - Purpose
Active ingredients (in each tablet) | Purpose |
---|---|
Acetaminophen 325 mg | Pain reliever |
Guaifenesin 200 mg | Expectorant |
Phenylephrine HCl 5 mg | Nasal decongestant |
Uses
- For the temporary relief of:
- sinus congestion and pressure
- nasal congestion
- headache
- minor aches and pains
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily relieves nasal congestion due to the common cold, hay fever and other upper respiratory allergies
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.
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.
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- diabetes
- thyroid disease
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
Otc - Ask Doctor/Pharmacist
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
- 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 is accompanied by a fever, rash or persistent headache
- nervousness, dizziness or sleeplessness occur. 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. (1-800-222-1222) Prompt 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 1-2 tablets every 4 hours as needed
- do not take more than 12 tablets in 24 hours, or as directed by a doctor
- consult a doctor
children under 12 years of age
Other Information
- store at room temperature 59-86°F (15-30°C)
- avoid excessive heat and humidity
Inactive Ingredients
FD&C red #40, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide
may contain
, sodium starch glycolate, starch, stearic acidQuestions Or Comments?
call toll-free 1-877-507-6516 (M-F 8AM – 4:30PM CST)
Principal Display Panel - 2 Tablet Packet Carton
Lil'
DrugStore®
Just what you need.SM
Convenient-Sized Relief
Multi-Symptom
Sinus
Acetaminophen,
Guaifenesin, Phenylephrine HCl
SEVERE
CONGESTION
Non-Drowsy Relief of
- Chest Congestion
- Nasal Congestion
- Sinus Pressure
50 PACKETS OF 2 TABLETS
27217
* Please review the disclaimer below.