Dosage form: liquid
Ingredients: ACETAMINOPHEN 500mg in 15mL, DEXTROMETHORPHAN HYDROBROMIDE 15mg in 15mL, DOXYLAMINE SUCCINATE 6.25mg in 15mL
Labeler: Pharmalab Enterprises Inc
NDC Code: 14505-399
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 Purpose
(in each 15 mL tablespoon)
Acetaminophen 500mg........ Pain Reliever/Fever Reducer
Dextromethorphan HBr 15mg...... Cough Suppressant
Doxylamine succinate 6.25mg..................Antihistamine
Uses: temporarily relieves common cold/flu symptoms:
- Cough due to Minor Throat and Bronchial Irritation
- Sore Throat
- Minor Aches and Pains
- runny nose and sneezing
Warnings: Do not exceed recommended dosage.
Do not give to children under 12 years of age.
Liver Toxicity may occur if:
- Recommended dosage is exceeded
- Used with other products containing acetaminophen
- Used with moderate amounts of alcohol
Sore Throat Warning: If sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.
Do not use 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 two 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
- Trouble urinating due to enlarged prostate gland
- Cough that occurs with too much phlegm(mucus)
- Persistent or chronic cough as occurs with smoking, asthma or emphysema
- Ask a doctor before use if you are taking sedatives or tranquilizers
When using this product, do not use more than directed
- Excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use and ask a doctor if:
- Pain 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. This could be signs of a serious condition.
If pregnant of breast-feeding, ask a health professional before use.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose can cause serious health problems. 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.
Directions: Take only as recommended. See Overdose Warning.
- use dose cup or tablespoon(TBSP). Do not use more than 4 doses in 24 hours
Adults and children 12 years and older: Take 2 TBSP(30ml) every 6 hours, while symptoms persist or as directed by a doctor
Children under 12 years of age: Consult a doctor. Do not use this adult extra strength product in children under 12 years of age. This will provide more than the recommended dose(overdose) of acetaminophen and cause serious problems.
- Store at controlled room temperature 15-30 C (59-86F)
each tablespoon contains: potassium 5 mg, sodium 18 mg. Contains 10% alcohol.
Questions? (302) 725-0692
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid
|Labeler - Pharmalab Enterprises Inc (174401088)|
|Registrant - Pharmalab Enterprises Inc (174401088)|
|Pharmalab Enterprises Inc||174401088||manufacture|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.