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  5. Label Information: D - Time

FDA Label for D - Time

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. OTC - WHEN USING
    7. STOP USE AND ASK DOCTOR IF
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTION
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. PRINCIPAL DISPLAY PANEL - 6000 CAPSULES LABEL

D - Time Product Label

The following document was submitted to the FDA by the labeler of this product Spirit Pharmaceuticals,llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

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.


Otc - Purpose



Active ingredients (in each LiquiCap)Purpose
Acetaminophen 325mgPain reliever/Fever Reducer
Dextromethorphan Hbr 10mgCough Suppressant
Phenylephrine HCl 5 mgNasal Decongestant

Indications & Usage



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

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

Otc - When Using



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


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use


Otc - Keep Out Of Reach Of Children



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

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 USP325 mg
Phenylephrine Hydrochloride USP5 mg
Dextromethorphan Hydrobromide USP10 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

Principal Display Panel - d time 01

Principal Display Panel - d time 01


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