N - TIME

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 325mg, DOXYLAMINE SUCCINATE 6.25mg, DEXTROMETHORPHAN HYDROBROMIDE 15mg
Labeler: SPIRIT PHARMACEUTICALS,LLC
NDC Code: 68210-1500

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.

N-Time Soft Gelatin Capsules

Drug Facts

Active ingredients (in each LiquiCap)Purpose
Acetaminophen 325mgPain reliever/Fever Reducer
Dextromethorphan Hbr 15Cough Suppressant
Doxylamine succinate 6.25mgAntihistamine

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing

Warnings

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

  • with other medicines containing acetaminophen
  • 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.

Ask a doctor before use if you have

  • Glaucoma
  • thyroid disease
  • trouble urinating due to enlarged postage gland
  • 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

Ask a doctor or pharmacists 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 doctor if

  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or less tan 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 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.

Direction
  • take only as recommended – see Overdose warning
  • do not exceed 6 doses per 24 Hours
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

Other information
  • each tablet contains : Store at room temperature

Inactive ingredients

FD &C Green No 3 IH, Polyethylene Glycol 400, Gelatin, Glycerin, Povidone, Purified water, Sorbitol

PRINCIPAL DISPLAY PANEL - 6000 Softgel Label

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"

N - TIME 
acetaminophen, doxylamine succinate, and dextromethorphan hydrobromide capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-1500
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
GELATIN 
POVIDONE 
SORBITOL 
WATER 
GLYCERIN 
FD&C GREEN NO. 3 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize18mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68210-1500-51 BAG (BAG) in 1 DRUM
15000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG
2NDC:68210-1500-61 BAG (BAG) in 1 DRUM
26000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG
3NDC:68210-1500-41 BAG (BAG) in 1 DRUM
34000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG
4NDC:68210-1500-81 BAG (BAG) in 1 DRUM
48000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/30/2010
Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)

Revised: 07/2010
 
SPIRIT PHARMACEUTICALS,LLC

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.

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