N - Time
FDA Label NDC 68210-1500

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 N - Time (NDC 68210-1500). 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 otc - purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Purpose

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

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.

Otc - Do Not Use

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.

Otc - Ask Doctor

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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacists before use if you are taking sedatives or tranquilizers.

Otc - When Using

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

Otc - Stop Use

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

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.

Other

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)

Principal Display Panel (6000 Softgel Label)

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