NITE TIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
PuraVation Pharmaceuticals Inc
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)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine Succinate 6.25 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Uses
temporarily relieves common cold/flu symptoms:
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches/pains
- fever
- runny nose & sneezing
Warnings
Liver warning: 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
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Sore throat warning: If sore throat is severe, persists 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.
- To make a child sleep
Ask a doctor before use if you have
- liver disease
- heart disease
- asthma
- emphysema
- thyroid disease
- diabetes
- glaucoma
- high blood pressure
- cough with excessive phlegm(mucus)
- breathing problems
- chronic bronchitis
- persistent or chronic cough
- cough associated with smoking
- difficulty in urinating due to an 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 exceed the recommended dosage
- do not use with other products containing acetaminophen
- do not use for more than 7 days
- excitability may occur especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop use and Ask a doctor if
- you get nervous, dizzy, or sleepless
- swelling or redness is present
- symptoms do not get better or are accompanied by a fever that lasts more than 3 days or if new symptoms occur
- cough lasts more than 7 days (adults) or 5 days (children), recurs or is accompanied by fever, rash, or persistent headache.
These may 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) could 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 children even if you do not notice any signs or symptoms.
Directions
- take only as recommended - see overdose warning
- do not exceed 4 doses per 24 hours
Adults and children 12 years of age and older
| Swallow 2 softgels with water every 6 hours |
Children 4 to 12 years of age
| ask a doctor |
children under 4 years of age
| do not use |
If taking NITE TIME and DAY TIME softgels carefully read each label to insure correct dosing.
Other information
- store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
- this product does not contain phenylpropanolamine (PPA)
Inactive ingredients
D&C Yellow # 10, FD&C Blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible ink
Questions or comments? Call toll free: 1-800-833-6278
PRINCIPAL DISPLAY PANEL
NITE TIME
LIQUID CAPS
ADULT NIGHTTIME COLD/FLU MEDICINE
Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
PAIN RELIEVER, FEVER REDUCER, COUGHT SUPPRESSANT, ANTIHISTAMINE
Compare to the active ingredients in Vicks® NyQuil®
