N - TIME

SPIRIT PHARMACEUTICALS,LLC

N-Time Soft Gelatin Capsules

FULL PRESCRIBING INFORMATION: CONTENTS*

• N - TIME Uses
• Warnings
• Direction
• N - TIME Other information
• Inactive ingredients
• PRINCIPAL DISPLAY PANEL - 6000 Softgel Label

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

N - TIME 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

N - TIME 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

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"