ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE- acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled
J.P. BUSINESS ENTERPRISE
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 softgel)||Purpose
|Acetaminophen 325 mg||Pain reliever/fever reducer
|Dextromethorphan Hydrobromide 15 mg||Cough suppressant
|Doxylamine Succinate 6.25 mg||Antihistamine
temporarily relieves common cold/flu symptoms:
- cough due to minor throat and bronchial irritation
- sore throat
- minor aches/pains
- runny nose and sneezing
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4 doses in 24 hours, which is the maximum daily amount for this product.
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Sore throat warning
If sore throat is severe, lasts for more than 2 days, or occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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.
- to make a child sleep
Ask a doctor before use if you have
- liver disease
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- trouble urinating due to enlarged prostate gland
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood-thinning drug warfarin.
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 with 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.
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.
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. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
- Take only as recommended—see
- do not exceed 4 doses per 24 hours
|adults and children 12 years of age and over||swallow 2 softgels with water every 6 hours
|children 4 to under 12 years of age||ask a doctor
|children under 4 years of age||do not use
If taking Nighttime and Daytime softgels carefully read each label to insure correct dosing
- store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
- this product does not contain phenylpropanolamine
D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide
Questions or comments?
Distributed By: J.P Business Enterprise
Lake Grove, NY 11755
PRINCIPAL DISPLAY PANEL - 10 Softgel Blister Pack Carton
SEE NEW WARNINGS INFORMATION
Compare to the active ingredients
COLD & FLU NIGHTTIME RELIEF
ACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE
Liquid filled capsules
J.P. BUSINESS ENTERPRISE