FDA Label for Acetaminophen, Dextromethorphan, Phenylephrine
View Indications, Usage & Precautions
Acetaminophen, Dextromethorphan, Phenylephrine Product Label
The following document was submitted to the FDA by the labeler of this product Agile Pharmachem. 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 Ingredient
(in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Purpose
pain reliever
Cough Suppressant
Nasal decongestant
Uses
pain reliever, cough suppressant and Nasal decongestant
Warnings
Warnings Failure to follow these warnings could result in serious consequences.
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hours which is maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
- with any other drug containing acetaminophen (prescription or not prescription). 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
- Heart disease
- Thyroid disease
- Diabetes
- High blood pressure
- Trouble urinating due to enlarged prostate gland
ask your 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:
- Redness or swelling is present
- You get nervous, dizzy or sleepless
- Fever gets worse or lasts more than 3 days
- New symptoms occur
- Symptoms do not get better within 7 days or are accompanied by a fever
do not use:
Ask a doctor before use if you have
Keep Out Of Reach Of Children.
If pregnant or breast-feeding, ask a health professional before use.
Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. 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.
Tamper evident: this package is safety sealed and child resistant. Use only if blisters are intact. If difficult to open use scissors.
Direction
- do not exceed 4 doses per 24 hours
- take only as directed – see overdose warning
- Adults and children 12 years and over: 2 softgels with water every 4 hours
- children under 12 years: ask a doctor
- Children under 4 years: do not use
Other Information
- store at room temperature
Inactive Ingredients
FD&C Red No.40, FD&C Yellow No. 6, Gelatin, Glycerin, Poyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol Special, Titanium dioxide
Questions Or Comments
Call toll free 1-855-314-1850
Package Label.Principal Display Panel
NDC: 58805-002-14 , 58805-002-08
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