NDC | 68210-1470-5, 68210-1470-6 |
Set ID | 87a8176e-9d32-4a8e-84ab-c81b2f74d46f |
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 for DayQuil Sinus (in each LiquiCap) Purpose Acetaminophen 325 mg Pain reliever Phenylephrine HCl 5 mg Nasal decongestant - Uses
temporarily relieves nasal and sinus symptoms:
- sinus pain
- headache
- nasal and sinus congestion
- runny nose and sneezing (NyQuil Sinus only)
- Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 doses in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure
- 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.
- to make a child sleep
Ask a doctor before use if you have
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- trouble urinating due to enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
When using these products
- do not use more than directed
In addition, when using NyQuil Sinus:
- 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 a doctor if
- redness or swelling is present
- symptoms do not get better within 7 days or are accompanied by a fever
- you get nervous, dizzy or sleepless
- fever gets worse or lasts more than 3 days
- new symptoms occur
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.
- Directions
- take only as recommended - see Overdose warning
- do not exceed 6 doses per 24 hours
NyQuil Sinus OR DayQuil Sinus
adults and children
12 years and over2 LiquiCaps with
water every 4 hourschildren 2 to under 12 years ask a doctor children under 2 years do not use - when using other DayQuil or NyQuil products, carefully read each label to insure correct dosing
- Other information
- Inactive ingredients
NyQuil Sinus FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide.
DayQuil Sinus FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide.
Close - PRINCIPAL DISPLAY PANEL - 6000 Softgels
D-Time Sinus Soft Gelatin Capsules
Each Softgel Contains:
Acetaminophen USP 325mg
Phenylephrine HCL USP 5mgLOT NO : NDC NO : 68210-1470-6 MFG DATE : QUANTITY : 6000 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
D TIME SINUS
acetaminophen and phenylephrine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-1470 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 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 YELLOW NO. 6 (UNII: H77VEI93A8) Product Characteristics Color ORANGE Score no score Shape OVAL Size 18mm Flavor Imprint Code 129 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-1470-5 1 in 1 DRUM 1 5000 in 1 BAG 2 NDC:68210-1470-6 1 in 1 DRUM 2 6000 in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 03/01/2010 Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)