FDA Label for Cold Medicine
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH TABLET)
- PURPOSES
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU
- 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 AND COMMENTS?
- PRINCIPAL DISPLAY PANEL
Cold Medicine Product Label
The following document was submitted to the FDA by the labeler of this product Selder, S.a. De C.v.. 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.
Active Ingredients (In Each Tablet)
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylephrine HCl 5 mg
Purposes
Pain reliever/fever reducer
Antihistamine
Nasal decongestant
Uses
temporarily relieves:
■ minor aches and pains
■ headaches
■ nasal congestion
■ sinus congestion & pressure
■ runny nose
■ sneezing
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
■ more than 12 tablets in 24 hours, which is the maximum daily amount
■ 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
■ if you are allergic to acetaminophen
■ more than 10 days unless directed by a doctor
■ 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
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask A Doctor Before Use If You Have
■ liver disease
■ heart disease
■ glaucoma
■ high blood pressure
■ thyroid disease
■ diabetes
■ trouble urinating due to an enlarged prostate gland
■ a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If You
■ are taking the blood thinning drug warfarin
■ are taking sedatives or tranquilizers
When Using This Product
■ do not use more than directed
■ excitability may occur, especially in children
■ may cause drowsiness n alcohol, sedatives, and tranquilizers may increase drowsiness
■ avoid alcoholic drinks n be careful when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
■ redness or swelling is present
■ new symptoms occur
■ you get nervous, dizzy, or sleepless n pain or nasal congestion gets worse or lasts for more than 7 days
■ fever gets worse or lasts for more than 3 days
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, contact a Poison Control Center (1-800-222-1222) immediately.
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 use more than directed
■ Adults and children 12 years of age and older: take 2 tablets every 6 hours. Do not take more than 12 tablets in 24 hours.
■ Children under 12 years of age: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
Other Information
■ store at room temperature in a dry place
■ do not use if blister package is torn.
Inactive Ingredients
corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid
Questions And Comments?
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