D - TIME- acetaminophen, phenylephrine hydrochloride, and dextromethorphan hydrobromide capsule, liquid filled

D - TIME by

Drug Labeling and Warnings

D - TIME by is a Otc medication manufactured, distributed, or labeled by SPIRIT PHARMACEUTICALS,LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

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

QUESTIONS

PRINCIPAL DISPLAY PANEL - 6000 Capsules Label

D-Time Soft Gelatin Capsules

• 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

SPL UNCLASSIFIED SECTION

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GELATIN (UNII: 2G86QN327L)
POVIDONE (UNII: FZ989GH94E)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	ORANGE	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-1490-5	1 in 1 DRUM
1		5000 in 1 BAG
2	NDC: 68210-1490-6	1 in 1 DRUM
2		6000 in 1 BAG
3	NDC: 68210-1490-4	1 in 1 DRUM
3		4000 in 1 BAG
4	NDC: 68210-1490-8	1 in 1 DRUM
4		8000 in 1 BAG

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)