FDA Label for Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl
View Indications, Usage & Precautions
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl Product Label
The following document was submitted to the FDA by the labeler of this product Opmx Llc. 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 - Active Ingredient
Acetaminophen 500mg
Chlorpheniramine Maleate 4mg
Phenylephrine HCl 10mg
Otc - Purpose
Pain reliever/fever reducer
Antihistamine
Nasal decongestant
Inactive Ingredient
magnesium stearate, povidone, silicon dioxide, sodium benzoate, sodium starch glycolate, starch, talc
Dosage & Administration
- Do not take more than directed - see overdose warning
- swallow whole; do not crush, chew or dissolve
- do not exceed 6 tablets per 24 hours
Adults and children 12 years of age & over | 1 tablet with water every 4-6 hours as needed |
Children 4 to 12 years of age | Ask a doctor |
Children under 4 years of age | Do not use |
Indications & Usage
Temporarily relieves these symptoms of hay fever or other respiratory allergies:
- Headache
- Nasal congestion
- Sinus congestion & pressure
- Runny nose and sneezing
- Minor aches & pain
- itching of the nose or throat
- itchy, watery eyes
- helps clear nasal passages
- helps decongest sinus opening and passages
Temporarily relieves these additional symptoms of hay fever:
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take :
- more than 6 tablets in 24 hours, which is the maximum daily amount for this product
- with other drugs contains acetaminophen
- 3 or more alcoholic drinks every day while using this product.
- skin reddening
- blisters
- rash
- 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.
- Liver disease
- High blood pressure
- Thyroid disease
- Diabetes
- Trouble urinating due to enlarged prostate gland
- A breathing problem such as emphysema or chronic bronchitis
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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 doctor promptly
Do not use:
Ask a doctor before use if you have:
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
When using this product, do not use more than directed.
Stop use and ask a doctor if:
You get nervous, dizzy, or sleepless
Pain, nasal congestion, or cough gets worse or lasts more than 7 days
Fever gets worse or last more than 3 days
Redness or swelling is present
New symptoms occur
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
OVERDOSE WARNING: Read directions carefully. 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.
Other Safety Information
store at room temperature between 20-25°C (68-77°F)
avoid excessive heat and humidity
* Please review the disclaimer below.