Otc - Active Ingredient
Acetaminophen 325mg
Dextromethorphan HBr 10mg
Guaifenesin 200mg
Phenylephrine HCl 5mg
The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Acetaminophen, Guaifenesin, Dextromethorphan Hbr, Phenylephrine Hcl (NDC 69729-782). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, inactive ingredient, dosage & administration, indications & usage, warnings, otc - keep out of reach of children, overdosage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 325mg
Dextromethorphan HBr 10mg
Guaifenesin 200mg
Phenylephrine HCl 5mg
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
Temporarily relieves common cold/flu symptoms:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses 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.
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: 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:
Liver disease
High blood pressure
Thyroid disease
Diabetes
Trouble urinating due to 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 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
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.
Keep out of reach of children.
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.
store at room temperature between 20-25°C (68-77°F)
avoid excessive heat and humidity
* Please review the disclaimer below.