RxRegimen check replace synthesize
Back to Library
FDA LABEL GENERIC: Acetaminophen MFR: DZA Brands LLC

Apap 325 Mg / Dextromethorphan Hydrobromide 10 Mg / Guaifenesin 200 Mg / Phenylephrine Hydrochloride 5 Mg Oral Capsule

Drug Facts

Active Ingredients (in each softgel)

Acetaminophen 325 mg 

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

temporarily relieves these common cold and flu symptoms: nasal congestion headache cough minor aches and pains sore throat temporarily reduces fever 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 12 softgels in 24 hours, which is the maximum  daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks daily 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 a 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 heart disease diabetes high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)

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

nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts 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.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 

Directions

do not take more than directed (see Overdose warning) do not take more than 12 liquid gels in any 24-hour period                                                                                               adults and children 12 years of age and older: take 2 liquid gels every 4 hours children under 12 years of age: do not use

Other information

store between 15-30°C (59-86°F) avoid excessive heat

Inactive ingredients

FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, and white edible ink

Questions or Comments?

Call: 1-866-322-2439

PRINCIPAL DISPLAY PANEL - Carton Label

CAREONE COLD, FLU & SORE THROAT RELIEF 16 SOFTGELS

NDC 55316-013-14

*Compare to the active ingredients in Mucinex® Fast-Max® Cold, Flu & Sore Throat