Pill Identifier Information of APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule
Drug Information
APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule
| Imprint: | |
| Shape: | C48345 |
| Color: | C48331 |
| Ingredients: | Acetaminophen; Dextromethorphan; Phenylephrine |
| Size: | 18.00 |
| Score: | 1 |
| Rxtty: | SY |
| Author: | SPIRIT PHARMACEUTICALS,LLC |
| Inactive Ingredients: | POLYETHYLENE GLYCOL 400 / PROPYLENE GLYCOL / GELATIN / POVIDONE / SORBITOL / WATER / GLYCERIN / FD&C RED NO. 40> |
Complete Information
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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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
- Other information
- Inactive ingredients
- QUESTIONS
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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
- SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
D - TIMEÂ
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)