Label: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE - acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled
view more68210-0101-5, 68210-0101-6
- Packager: SPIRIT PHARMACEUTICALS, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated September 1, 2010
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active ingredients (in each LiquiCap) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant
temporarily relieves common cold/flu symptoms:
- nasal congestion
- cough due to minor throat and bronchial irritation
- sore throat
- minor aches and pains
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
- 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.
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.
- Other information
- store at room temperature
- Inactive ingredients
FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxideClose
- 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)
NDC NO: 68210-0101-
KEEP OUT OF REACH OF CHILDREN
STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING
THIS 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.
SOFTGEL HEALTHCARE PVT LIMITED
LABELLER CODE: 35916
LIC NO.: TN/DRUGS/00002124
SPIRIT PHARMACEUTICALS LLC
225 LINCOLN HWY, STE 205
FAIRLESS HILLS, PA 19030
PH.# 215 943 4000
FAX.# 215 943 4039
CAUTION: "FOR MANUFACTURING, PROCESSING OR REPACKING"
- 1 – 4
- 2 – 100
- 3 – 1000
- 4 – 5000
- 5 – 10000
6 - 2500
- INGREDIENTS AND APPEARANCE
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled
Product 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)