D - Time
FDA Label NDC 68210-1490

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals,llc for the product D - Time (NDC 68210-1490). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, indications & usage, do not use, ask a doctor before use if you have, otc - when using, stop use and ask doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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