OTC Medication Information: D – TIME

D — TIME- acetaminophen, phenylephrine hydrochloride and dextromethorphan hydrobromide capsule, liquid filled
SPIRIT PHARMACEUTICALS,LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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

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

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

Principal Display Panel
(click image for full-size original)

D — TIME
acetaminophen, phenylephrine hydrochloride, and dextromethorphan hydrobromide capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-1490
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 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 ORANGE Score no score
Shape OVAL Size 18mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68210-1490-5 1 BAG (BAG) in 1 DRUM contains a BAG
1 5000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG This package is contained within the DRUM (68210-1490-5)
2 NDC:68210-1490-6 1 BAG (BAG) in 1 DRUM contains a BAG
2 6000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG This package is contained within the DRUM (68210-1490-6)
3 NDC:68210-1490-4 1 BAG (BAG) in 1 DRUM contains a BAG
3 4000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG This package is contained within the DRUM (68210-1490-4)
4 NDC:68210-1490-8 1 BAG (BAG) in 1 DRUM contains a BAG
4 8000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG This package is contained within the DRUM (68210-1490-8)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 05/30/2010
Labeler — SPIRIT PHARMACEUTICALS,LLC (179621011)

Revised: 07/2010 SPIRIT PHARMACEUTICALS,LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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