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Name:N - Time
Manufacturer:Spirit Pharmaceuticals,llc
Category:Over-the-counter (OTC) Marketed Drugs


N-Time Soft Gelatin Capsules

N - TIME - acetaminophen, doxylamine succinate and dextromethorphan hydrobromide capsule, liquid filled 
SPIRIT PHARMACEUTICALS,LLC

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.

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N-Time Soft Gelatin Capsules

Drug Facts

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

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"

Principal Display Panel - 6000 Softgel Label

N - TIME 
acetaminophen, doxylamine succinate, and dextromethorphan hydrobromide capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-1500
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 6.25 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 15 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 400  
PROPYLENE GLYCOL  
GELATIN  
POVIDONE  
SORBITOL  
WATER  
GLYCERIN  
FD&C GREEN NO. 3  
Product Characteristics
Color GREEN Score no score
Shape OVAL Size 18mm
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68210-1500-5 1 BAG ( BAG) in 1 DRUM contains a BAG
1 5000 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BAG This package is contained within the DRUM (68210-1500-5)
2 NDC:68210-1500-6 1 BAG ( BAG) in 1 DRUM contains a BAG
2 6000 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BAG This package is contained within the DRUM (68210-1500-6)
3 NDC:68210-1500-4 1 BAG ( BAG) in 1 DRUM contains a BAG
3 4000 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BAG This package is contained within the DRUM (68210-1500-4)
4 NDC:68210-1500-8 1 BAG ( BAG) in 1 DRUM contains a BAG
4 8000 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BAG This package is contained within the DRUM (68210-1500-8)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 05/30/2010

Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)

Revised: 07/2010 SPIRIT PHARMACEUTICALS,LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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