Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Medically reviewed on January 10, 2018
Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: AAA Pharmaceutical, Inc.
NDC Code: 57344-138
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
|Active ingredients (in each caplet)||Purpose|
|Acetaminophen 325 mg||Pain reliever/fever reducer|
|Dextromethorphan HBr 10 mg||Cough suppressant|
|Phenylephrine HCl 5 mg||Nasal decongestant|
- temporarily relieves these common cold/flu symptoms:
- minor aches and pains
- sore throat
- nasal congestion
- sinus congestion and pressure
- helps clear nasal passages
- promotes nasal and sinus drainage
- temporarily reduces fever
This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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.
- 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, 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
- 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.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- do not take more than directed (see overdose warning)
|adults and children 12 years and over||
|children under 12 years||
- store between 20-25°C (68-77°F) in a dry place
- retain carton for complete product information
acesulfame potassium, colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048
†COMPARE TO THE ACTIVE
INGREDIENTS IN TYLENOL® COLD
MULTI-SYMPTOM - DAYTIME
See New Warnings
Information & Directions
Pain Reliever/Fever Reducer, Nasal Decongestant, Cough Suppressant
- Headache/Fever/Sore Throat – Acetaminophen
- Nasal Congestion – Phenylephrine HCl
- Coughing – Dextromethorphan HBr
|ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet, coated
|Labeler - AAA Pharmaceutical, Inc. (181192162)|