Otc - Purpose
| Active ingredients (in each LiquiCap) | Purpose |
|---|---|
| Acetaminophen 325mg | Pain reliever/Fever Reducer |
| Dextromethorphan Hbr 15 | Cough Suppressant |
| Doxylamine succinate 6.25mg | Antihistamine |
The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals,llc for the product N - Time (NDC 68210-1500). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
| Active ingredients (in each LiquiCap) | Purpose |
|---|---|
| Acetaminophen 325mg | Pain reliever/Fever Reducer |
| Dextromethorphan Hbr 15 | Cough Suppressant |
| Doxylamine succinate 6.25mg | Antihistamine |
temporarily relieves common cold/flu symptoms:
Alcohol Warnings :if you consume 3 or more alcoholic drinks every day, ask you doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.
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
Ask a doctor before use if you have
Ask a doctor or pharmacists before use if you are taking sedatives or tranquilizers.
when using this product
Stop use and ask doctor if
These could be signs of a serious conditions
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 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.
| adults and children 12 years of age and older | -2 liquicaps with water every 6 hours |
| children under 12 years of age | - ask a doctor |
FD &C Green No 3 IH, Polyethylene Glycol 400, Gelatin, Glycerin, Povidone, Purified water, Sorbitol
N-Time Soft Gelatin Capsules
Each Soft gelatin capsule contains :
Acetaminophen USP 325 mg
Dextromethorphan Hydrobromide USP 15 mg
Doxylamine Succinate USP 6.25 mg
| LOT NO : | NDC NO : 68210-1500-6 |
| MFG DATE : | QUANTITY : 1000 X 6 Softgels |
| EXP DATE : | GROSS WT. : |
WARNING:
KEEP OUT OF REACH OF CHILDREN
STORE AT CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING
THIS BULK SHIPMENT IS INTENDED FOR FURTHER PACKAGING PROCESS ONLY.
CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT
CONFORMANCE WITH THE FD & C ACT AND REGULATIONS THEREUNDER.
MANUFACTURED BY:
Marksans Pharma Ltd
VERNA, GOA-403722,
INDIA.
CODE : GO/DRUGS/515
MANUFACTURED FOR:
SPIRIT PHARMACEUTICALS LLC
225 LINCOLN HWY, STE 205
FAIRLESS HILLS, PA 19030
PH.# 215 943 4000
FAX.# 215 943 4039
CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"
* Please review the disclaimer below.