Acetaminophen,Dextromethorphan,Phenylephrine

Agile Pharmachem
Agile Pharmachem

Acetaminophen, Dextromethorphan and Phenylephrine Day time Cold and Flu

FULL PRESCRIBING INFORMATION

(in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

pain reliever

Cough Suppressant

Nasal decongestant

pain reliever, cough suppressant and Nasal decongestant

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

do not use:

• 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.

Ask a doctor before use if you have

• 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

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.

• 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

• store at room temperature

FD&C Red No.40, FD&C Yellow No. 6, Gelatin, Glycerin, Poyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol Special, Titanium dioxide

Call toll free 1-855-314-1850

NDC: 58805-002-14