FDA Label for Cold Severe Congestion
View Indications, Usage & Precautions
- DRUG FACTS
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- LIVER WARNING
- ALLERGY ALERT
- SORE THROAT WARNING
- 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
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PDP/PACKAGE
Cold 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.
Drug Facts
Drug Facts
Active Ingredients
Active ingredients (in each tablet)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Guaifenesin 200 mg
Phenylephrine HCI 5 mg
Purpose
Purpose
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Uses
Uses
■ for the temporary relief of the following cold/flu symptoms:
■ minor aches and pains
■ headache
■ sore throat
■ nasal congestion
■ cough
■ impulse to cough
■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
■ temporarily reduces fever
Liver Warning
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
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
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.
A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
Do Not Use
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
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
Ask A Doctor Or Pharmacist Before Use If You Are
Ask a doctor or pharmacist before use if you are
■ taking the blood thinning drug warfarin
When Using This Product
When using this product
■ do not exceed recommended dosage
Stop Use And Ask A Doctor If
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.
If Pregnant Or Breast-Feeding
If pregnant or breast-feeding, ask a health professional before use.
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
Directions
adults and children 12 years and over | ■ take 2 tablets with water every 6-8 hours as needed ■ do not take more than 8 tablets in 24 hours, or as directed by a doctor |
children under 12 years of age | ask a doctor |
Other Information
Other information
■ store at room temperature 59-86˚ F (15-30˚ C)
Inactive Ingredients
Inactive ingredients
maltodextrin, microcrystalline cellulose, povidone, silicon dioxide*, sodium starch glycolate, starch, stearic acid
*may contain
Questions Or Comments?
Questions or comments?
call toll-free
1-877-507-6516 (M-F 8AM-4:30PM CST)
Pdp/Package
Cold
Acetaminophen, Dextromethorphan HBr,
Guaifenesin, Phenylephrine HCl
SEVERE
CONGESTION
Non-Drowsy Relief of
- Cough, Im[pulse to Cough
- Nasal Congestion
- Sore Throat
- 50 PACKETS OF 2 TABLETS
[barcode]
3 66715 97187 6
* Please review the disclaimer below.