FDA Label for Acetaminophen, Guaifenesin, Dextromethorphan Hbr, Phenylephrine Hcl
View Indications, Usage & Precautions
Acetaminophen, Guaifenesin, Dextromethorphan Hbr, 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 325mg
Dextromethorphan HBr 10mg
Guaifenesin 200mg
Phenylephrine HCl 5mg
Otc - Purpose
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Inactive Ingredient
FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
Dosage & Administration
- Take only as directed (See overdose warning)
- Do not exceed 4 doses per 24-hours
- Adults and children 12 years and over: take 2 softgels with water every 4 hours
- Children 4 to under 12 years: ask a doctor
- When using other Nighttime or Daytime products, carefully read each label to ensure correct dosing
Indications & Usage
Temporarily relieves common cold/flu symptoms:
- Nasal congestion
- Sinus congestion & pressure
- Cough due to minor throat & bronchial irritation
- Minor aches & pain
- Headache
- Fever
- Sore throat
- Reduces swelling of nasal passages
- Temporarily restore freer breathing through the nose
- Promotes nasal and/or sinus drainage
- Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Warnings
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:
- 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
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.
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.