NDC | 68210-0101-1, 68210-0101-2, 68210-0101-3, 68210-0101-4, 68210-0101-5, 68210-0101-6 |
Set ID | 17aebf77-55d8-4a02-8391-28bbd9c3b373 |
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
- Uses
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Warnings
Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your 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 prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
Stop use and ask a 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 lasts more than 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 condition.
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Directions
- take only as recommended - see Overdose warning
- do not exceed 6 doses per 24 hours
adults and children 12 years and over 2 LiquiCaps with water every 4 hours children under 12 years ask a doctor - when using other DayQuil or NyQuil products, carefully read each label to insure correct dosing
- Other information
- Inactive ingredients
- Questions?
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PRINCIPAL DISPLAY PANEL
Acetaminophen, Dextromethorphan HBr Phenylephrine HCL capsules
Each Softgel Contains:
(Acetaminophen USP 325 mg, Dextromethorphan Hydrobromide USP 10 mg,
Phenylephrine Hydrochloride USP 5mg)LOT NO:
DRUM NO:
MFG DATE:
QUANTITY:
NDC NO: 68210-0101-
EXP DATE:WARNING:
KEEP OUT OF REACH OF CHILDRENSTORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZINGTHIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH
THE F.D & C.ACT AND REGULATIONS THEREUNDER.MANUFACTURED BY:
SOFTGEL HEALTHCARE PVT LIMITED
INDIA
LABELLER CODE: 35916
LIC NO.: TN/DRUGS/00002124MANUFACTURED 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"
- 1 – 4
- 2 – 100
- 3 – 1000
- 4 – 5000
- 5 – 10000
6 - 2500
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-0101 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) GELATIN (UNII: 2G86QN327L) POVIDONE (UNII: FZ989GH94E) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Product Characteristics Color ORANGE Score no score Shape OVAL Size 20mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-0101-1 4 in 1 BOX 2 NDC:68210-0101-2 100 in 1 BOX 3 NDC:68210-0101-3 1000 in 1 BOX 4 NDC:68210-0101-4 5000 in 1 BOX 5 NDC:68210-0101-5 10000 in 1 BOX 6 NDC:68210-0101-6 2500 in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 10/15/2009 Labeler - SPIRIT PHARMACEUTICALS, LLC (179621011)