NDC | 68210-1490-4, 68210-1490-5, 68210-1490-6, 68210-1490-8 |
Set ID | 381867b1-d857-4265-8d99-33b400934967 |
Category | HUMAN OTC DRUG LABEL |
Packager | SPIRIT PHARMACEUTICALS,LLC |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- 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
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
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
- Inactive ingredients
FD &C Red No 40 IH, Polyethylene Glycol 400, Gelatin, Glycerin, Povidone, Purified water, Sorbitol
Close - 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 CHILDRENSTORE AT CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30 °C)
PROTECT FROM LIGHT, MOISTURE AND FREEZINGTHIS 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/515MANUFACTURED FOR:
SPIRIT PHARMACEUTICALS LLC
225 LINCOLN HWY, STE 205
FAIRLESS HILLS, PA 19030
PH.# 215 943 4000
FAX.# 215 943 4039CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"
OGIL056
- INGREDIENTS AND APPEARANCE
D - TIME
acetaminophen, phenylephrine hydrochloride, and dextromethorphan hydrobromide capsule, liquid filledProduct 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)