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D - TIME

SPIRIT PHARMACEUTICALS,LLC

D-Time Soft Gelatin Capsules


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each LiquiCap) Purpose
Acetaminophen 325mg Pain reliever/Fever Reducer
Dextromethorphan Hbr 10mg Cough Suppressant
Phenylephrine HCl 5 mg Nasal Decongestant

Uses

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • nasal congestion

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

  • heart disease
  • thyroid disease
  • Diabetes
  • high blood pressure
  • trouble urinating due to enlarged postage gland
  • cough that occurs with too much phlegm(mucus)
  • persistent or chronic cough as occurs with smoking, asthma or emphyesma

when using this product do not use more than directed

Stop use and ask doctor if

  • you get nervous,dizzy or sleepless
  • symptoms get worse or last more than 5 days (children) or 7 days (adults)
  • 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 4 hours
children under 12 years of age - ask a doctor

D - TIME Other information

  • each tablet contains : Store at room temperature

Inactive ingredients

FD &C Red No 40 IH, Polyethylene Glycol 400, Gelatin, Glycerin, Povidone, Purified water, Sorbitol

PRINCIPAL DISPLAY PANEL - 6000 Capsules Label

D-Time Soft Gelatin Capsules

Each soft gelatin capsule contains :
Acetaminophen USP 325 mg
Phenylephrine Hydrochloride USP 5 mg
Dextromethorphan Hydrobromide USP 10 mg
LOT NO : NDC NO : 68210-1490-6
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"

OGIL056

D - TIME

D - TIME

ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68210-1490
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg

Inactive Ingredients

Ingredient Name Strength
polyethylene glycol 400
propylene glycol
GELATIN
povidone
sorbitol
water
GLYCERIN
FD&C RED NO. 40

Product Characteristics

Color Size Shape
ORANGE 18 mm OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5000 in 1 BAG
2 6000 in 1 BAG
3 4000 in 1 BAG
4 8000 in 1 BAG
5 NDC:68210-1490-8 1 in 1 DRUM

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-05-30


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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