NDC | 68210-1500-4, 68210-1500-5, 68210-1500-6, 68210-1500-8 |
Set ID | 390a0c89-a640-4a0b-aaf3-955b502fb33a |
Category | HUMAN OTC DRUG LABEL |
Packager | SPIRIT PHARMACEUTICALS,LLC |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active ingredients (in each LiquiCap) Purpose Acetaminophen 325mg Pain reliever/Fever Reducer Dextromethorphan Hbr 15 Cough Suppressant Doxylamine succinate 6.25mg Antihistamine - 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.
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
- 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
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
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
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
- Inactive ingredients
FD &C Green No 3 IH, Polyethylene Glycol 400, Gelatin, Glycerin, Povidone, Purified water, Sorbitol
Close - 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 mgLOT NO : NDC NO : 68210-1500-6 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"
- INGREDIENTS AND APPEARANCE
N - TIME
acetaminophen, doxylamine succinate, and dextromethorphan hydrobromide capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-1500 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 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 GREEN NO. 3 (UNII: 3P3ONR6O1S) Product Characteristics Color GREEN Score no score Shape OVAL Size 18mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-1500-5 1 in 1 DRUM 1 5000 in 1 BAG 2 NDC:68210-1500-6 1 in 1 DRUM 2 6000 in 1 BAG 3 NDC:68210-1500-4 1 in 1 DRUM 3 4000 in 1 BAG 4 NDC:68210-1500-8 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)